FDA Adverse Event
Injury
Summary report: N
DELTA CERAMIC FEM HD 36/ 0MM (T1)
MDR report key: 3070590
·
Received April 22, 2013
Report
- Report Number
- 3002806535-2013-00062
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 4, 2013
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LZO
- PMA / PMN Number
- PK061312
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY HIP PROCEDURE ON (B)(6) 2013. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO POST OP INFECTION. NO FURTHER INFORMATION HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 170992 | DELTA CERAMIC FEM HD 36/ 0MM (T1) | BIOLOX CERAMIC HEAD | LZO | BIOMET UK LTD. | N/A | 2718284 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |