FDA Adverse Event
Injury
Summary report: N
LATERALIZD HUM CUP DIA 36+6MM
MDR report key: 1080911
·
Received July 22, 2008
Report
- Report Number
- 1818910-2008-02893
- Event Type
- Injury
- Date Received
- July 22, 2008
- Date of Event
- June 26, 2008
- Report Date
- June 26, 2008
- Manufacturer
- DEPUY FRANCE S.A.
- Product Code
- KWS
- PMA / PMN Number
- K021478
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS LOOSENING OF THE METAGLENE AND POLY WEAR OF THE HUMERAL CUP. THE REPORT STATES THAT THE PT HAD POOR BONE STOCK THAT COULD NOT HOLD THE METAGLENE, AND THAT THE PT WAS REVISED TO A HEMI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LATERALIZD HUM CUP DIA 36+6MM | 87KWS | KWS | DEPUY FRANCE S.A. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |