FDA Adverse Event
Injury
Summary report: N
PCA ACE/LOW PROFILE SHELL 55MM
MDR report key: 1221888
·
Received November 4, 2008
Report
- Report Number
- 2249697-2008-00338
- Event Type
- Injury
- Date Received
- November 4, 2008
- Date of Event
- October 2, 2008
- Report Date
- October 6, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KWB
- PMA / PMN Number
- K920831
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE FOR EVALUATION. NO EVALUATION WILL BE PERFORMED. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT "CUP WAS LOOSE. WE EXPLANTED THE SHELL, LINER AND FEMORAL HEAD. REPLACED WITH ZIMMER SHELL AND LINER A STRYKER 36MM X +10MM PCA FEMORAL HEAD."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PCA ACE/LOW PROFILE SHELL 55MM | IMPLANT | KWB | STRYKER ORTHOPAEDICS MAHWAH | NA | PCVWA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |