FDA Adverse Event
Injury
Summary report: N
DUROM US ACETABAR COMPONENT 56/50 P
MDR report key: 1842810
·
Received September 15, 2010
Report
- Report Number
- 9613350-2010-00438
- Event Type
- Injury
- Date Received
- September 15, 2010
- Date of Event
- August 19, 2010
- Report Date
- August 25, 2010
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER DID NOT YET RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. IT IS NOT SUSPECTED THAT DEVICE FAILURE OR MALFUNCTION LEAD TO THE REPORTED INCIDENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).
Description of Event or Problem · 1
IT IS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUROM US ACETABAR COMPONENT 56/50 P | DUROM ACETABULAR COMPONENT AND METASUL | KWA | ZIMMER GMBH | NA | 2437093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization |