FDA Adverse Event
Injury
Summary report: N
RECIPROCATING/OSCILLATING SAW/MODULAT HANDPIECE
MDR report key: 4152590
·
Received October 2, 2014
Report
- Report Number
- MW5038507
- Event Type
- Injury
- Date Received
- October 2, 2014
- Date of Event
- August 5, 2014
- Manufacturer
- CONMED LINVATEC
- Product Code
- HBC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT UNDERWENT REVISION OF RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2014 UTILIZING THE STRYKER CEMENTLESS TITANIUM KNEE SYSTEM. IMMEDIATELY POSTOP, PT DEVELOPED EARLY SUBSIDENCE OF THE IMPLANT WITH PAIN AND INSTABILITY AND REQUIRED REVISION SURGERY. IT WAS OPINED THAT THE RADIOGRAPHIC FINDINGS COULD BE AS A RESULT OF THE UNEVEN CUTS OBTAINED BY THE POWER EQUIPMENT AND EXCESS HEAT GENERATED BY THE BLADE SYSTEM. THE SURGEON HAS IDENTIFIED NINE OTHER CASES WITH SIMILAR RADIOGRAPHIC FINDINGS INCLUDING ONE THAT IS PENDING REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 614266 | RECIPROCATING/OSCILLATING SAW/MODULAT HANDPIECE | RECIPROCATING/OSCILLATING SAW/MODULAR HANDPIECE | HBC | CONMED LINVATEC | |||
| 614267 | RECIPROCATING/OSCILLATING SAW/MODULAR HANDPIECE | RECIPROCATING/OSCILLATING SAW/MODULAR HANDPIECE | HBC | CONMED LINVATEC | |||
| 614498 | RECIPROCATING/OSCILLATING SAW/MOLDAR HANDPIECE | RECIPROCATING/OSCILLATING SAW/MOLDAR HANDPIECE | HBC | CONMED LINVATEC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |