Chapter 7 Strength Testing: Isokinetic Testing & Evaluation (Class II Devices)
This section reviews complications during isokinetic testing. Nine knee (or related) injuries were reported to the FDA from 5/28/97 to 6/25/99 in Maude and from 5/14/96 to 11/26/86 in MDR (also see Exercise equipment for injuries not specifically related to testing).1
| Date | Device during Testing | Event |
|---|---|---|
| 5/14/96 | KIN-COM | A patient with an ACL surgery sustained a patella fracture during maximal strength testing. Note: No unit malfunction was noted. |
| 9/05/95 | VIDO ACTIVE | A 52-year-old female was 7 weeks post-op for a TKR and had received 4 weeks of PT. During testing, the patient felt something snap/move, resulting in extreme swelling and pain. Note: No unit malfunction was noted. |
| 6/16/95 | KINCOME | A 34-year-old female was s/p patella tendon graft for an ACL repair 14 weeks earlier. During a post-op evaluation, a loud pop was heard with the patella fracturing. No unit malfunction was found. |
| 11/19/93 | KINCOM II | During concentric and eccentric right knee testing, the actuator head moved, resulting in knee discomfort in the user. |
| 5/10/93 | KINCOM I | A man sustained a laceration to the lower leg during quadriceps testing at 80 degrees/sec in a concentric/eccentric mode when the unit’s head tilted unexpectedly. |
| 2/15/93 | KINCOM 125 E+ | During bilateral dual speed isokinetic knee flexion/extension testing at 100 degrees/sec, the actuator head, which was not locked, rotated and resulted in back strain in the user’s muscles. |
| 1/05/93 | CYBEX 6000 | During testing, the unit’s adapter separated from the device, requiring additional left knee surgery in the user. |
| 11/06/92 | KINCOM II | During knee testing (comparison) at 180 degrees/sec in an eccentric mode, the user felt knee pain (no details). |
| 2/10/92 | ISOTECHNOLOGIES | A patient s/p rectal surgery re-injured a sphincter muscle during testing. |
Note: FDA reports do not necessarily establish cause–effect relationships between equipment and injury. Incidences may be due to equipment or user error. Also, some reports are alleged by attorneys.
1 US Food and Drug Administration. Center for Device and Radiological Health. Available at: http://www.fda.gov/cdrh/mdr/. Accessed November 7, 2005
2 Schmitz TJ. Traumatic spinal cord injury. In O’Sullivan SB, Schmitz TJ, editors: Physical rehabilitation: Assessment and treatment, ed 4, Philadelphia: FA Davis, 2001.
