FDA Adverse Event
Injury
Summary report: N
UNKNOWN ACETABULAR CUP
MDR report key: 2161157
·
Received July 8, 2011
Report
- Report Number
- 2249697-2011-01010
- Event Type
- Injury
- Date Received
- July 8, 2011
- Date of Event
- June 15, 2011
- Report Date
- June 15, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KWB
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO HAS BEEN REQUESTED AND IF OBTAINED WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "CUP WAS LOOSE. TOOK OUT ALL IMPLANTS. USED STRYKER HEAD, ACETABULAR CUP & LINER. DOCTOR REIMPLANTED WITH ZIMMER PRODUCTS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN ACETABULAR CUP | IMPLANT | KWB | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |