FDA Adverse Event
Other
Summary report: N
UNKNOWN DEPUY ASR HIP (LEFT SIDE)
MDR report key: 2113678
·
Received May 11, 2011
Report
- Report Number
- 1818910-2011-08270
- Event Type
- Other
- Date Received
- May 11, 2011
- Report Date
- April 11, 2011
- Manufacturer
- DEPUY INTERNATIONAL, LTD
- Product Code
- KWA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
PATIENT CONTACTED BROADSPIRE TO INITIATE CLAIM. PATIENT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336102 | UNKNOWN DEPUY ASR HIP (LEFT SIDE) | TOTAL HIP PROSTHESIS | KWA | DEPUY INTERNATIONAL, LTD | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |