FDA Adverse Event
Other
Summary report: N
BIOLOX DELTA HEAD, 12/14, 36 X 0
MDR report key: 3202060
·
Received June 20, 2013
Report
- Report Number
- 9613350-2013-01655
- Event Type
- Other
- Date Received
- June 20, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 3, 2013
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MFR DID NOT RECEIVE ANY DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT IS AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS IMPLANTED WITH A BIOLOX DELTA HEAD, 12/14, 36 X 0 ON (B)(6) 2011. TO DATE, THE PT HAS NOT BEEN REVISED. CURRENTLY, THE PT IS BEING MONITORED DUE TO PAIN. ACCORDING TO THE PT'S REPORT, THE X-RAYS LOOK FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281431 | BIOLOX DELTA HEAD, 12/14, 36 X 0 | BIOLOX DELTA CERAMIC FEMORAL HEAD | LZO | ZIMMER GMBH | 2596944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |