FDA Adverse Event
Injury
Summary report: N
ASR UNI FEMORAL IMPL SIZE 45
MDR report key: 2111386
·
Received May 13, 2011
Report
- Report Number
- 1818910-2011-08187
- Event Type
- Injury
- Date Received
- May 13, 2011
- Date of Event
- January 11, 2011
- Report Date
- April 14, 2011
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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
THE PT WAS REVISED TO ADDRESS CUP LOOSENING. MEDICAL RECORDS WERE REC'D. THE REVISION DATE WAS CORRECTED. ADDITIONALLY INFO CONTAINED IN THE MEDICAL RECORDS INDICATES THAT SUSPICIOUS LOOKING TISSUE WAS FOUND DURING SURGERY CONSISTENT WITH ALVAL. THE FEMORAL HEAD WAS ADDED TO THE COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR UNI FEMORAL IMPL SIZE 45 | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | 2375981 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |