FDA Adverse Event
Injury
Summary report: N
TRIATHLON CR FEM COMP #3 L-CEM
MDR report key: 2234023
·
Received August 29, 2011
Report
- Report Number
- 9610726-2011-00297
- Event Type
- Injury
- Date Received
- August 29, 2011
- Date of Event
- August 8, 2011
- Report Date
- August 8, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K040267
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
DOCTOR REVISED A LEFT TRIATHLON KNEE AS THE PT HAD PAIN. HE RESURFACED THE PATELLA AS THE PT'S PATELLA HAD NOT BEEN RESURFACED IN THE ORIGINAL SURGERY. THE SURGEON SAID THE PT COMPLAINED OF PAIN AT APPROX 6 MONTHS POST SURGERY AT A CHECK UP. DOCTOR REMOVED THE PT'S 11MM CR INSERT AND REPLACED IT WITH A 13MM CS LIPPED INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON CR FEM COMP #3 L-CEM | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | SLF7P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |