FDA Adverse Event
Malfunction
Summary report: N
MODIFIED HOLLOW PS TIBIAL INSERT TRIAL #3 - 9MM
MDR report key: 4090569
·
Received September 15, 2014
Report
- Report Number
- 0002249697-2014-03478
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Date of Event
- August 25, 2014
- Report Date
- August 25, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K123166
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 1
REVIEW OF THE DEVICE HISTORY RECORDS INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE REPORTED EVENT WAS CONFIRMED. A PORTION OF THE DISTAL RAILS OF THE TRIATHLON PS TRIAL FRACTURED. SCRATCHES AND INDENTATIONS WERE OBSERVED ON THE ARTICULATING SURFACE, UNDERSIDE, AND DISTAL RAILS.
Description of Event or Problem · 1
IT WAS REPORTED DURING PRIMARY RIGHT KNEE SURGERY A SMALL PIECE OF THE TRIAL POLY INSERT COMPONENT BROKE OFF.
Description of Event or Problem · 1
IT WAS REPORTED DURING PRIMARY RIGHT KNEE SURGERY A SMALL PIECE OF THE TRIAL POLY INSERT COMPONENT BROKE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 569908 | MODIFIED HOLLOW PS TIBIAL INSERT TRIAL #3 - 9MM | INSTRUMENT | JWH | STRYKER ORTHOPAEDICS-MAHWAH | 2PPM5J22 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |