FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT - HEMISPHERICAL ACETABULAR CUP
MDR report key: 1132044
·
Received August 21, 2008
Report
- Report Number
- 2249697-2008-00238
- Event Type
- Injury
- Date Received
- August 21, 2008
- Date of Event
- July 28, 2008
- Report Date
- July 28, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KWB
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE WITH ADDITIONAL INFORMATION, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED / ALLEGED BY PATIENT THAT, 'INJURIES RESULTING FROM A HEMISPHERICAL ACETABULAR CUP WHICH WAS IMPLANTED IN 2003, WHICH REQUIRED REVISED IN 2008."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT - HEMISPHERICAL ACETABULAR CUP | IMPLANT | KWB | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |