FDA Adverse Event
Injury
Summary report: N
DUROM ACETABULAR COMPONENT
MDR report key: 2299633
·
Received October 11, 2011
Report
- Report Number
- 9613350-2011-00663
- Event Type
- Injury
- Date Received
- October 11, 2011
- Date of Event
- August 25, 2011
- Report Date
- September 20, 2011
- Manufacturer
- ZIMMER INC
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC, WHICH MARKETS THE DEVICES IN THE US. THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. SHOULD ADD'L INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, 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 PT UNDERWENT TOTAL HIP ARTHROPLASTY AND WAS REVISED FOR UNK REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUROM ACETABULAR COMPONENT | DUROM ACETABULAR COMPONENT AND METASUL | KWA | ZIMMER INC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |