FDA Adverse Event
Injury
Summary report: N
ALLOCLASSIC SL STEM 01 12/14
MDR report key: 2041303
·
Received March 25, 2011
Report
- Report Number
- 9613350-2011-00179
- Event Type
- Injury
- Date Received
- March 25, 2011
- Report Date
- March 2, 2011
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT ZIMMER INC., WHICH MARKETS THE DEVICES IN (B)(6). THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE REC'D FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION 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 DISLOCATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLOCLASSIC SL STEM 01 12/14 | ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL | LZO | ZIMMER GMBH | 2303161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |