FDA Adverse Event
Injury
Summary report: N
ACETABULAR AUGMENT
MDR report key: 2200733
·
Received July 26, 2011
Report
- Report Number
- 3005751028-2011-00051
- Event Type
- Injury
- Date Received
- July 26, 2011
- Date of Event
- June 3, 2009
- Report Date
- July 25, 2011
- Manufacturer
- ZIMMER TMT
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LIMITED INFO IS AVAILABLE AT THIS TIME. ROOT CAUSE AND FURTHER DETAILS ON THE EVENT ARE NOT AVAILABLE FOR REVIEW. SHOULD ADDITIONAL INFO BE RECEIVED WHICH WILL FURTHER THIS INVESTIGATION THIS REPORT SHALL BE UPDATED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PT'S COUNSEL THAT THE PT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2007. THE PT EXPERIENCED PAIN IN HIS HIP, BUTTOCK, SCIATIC NERVE AND LEFT LEG. A REVISION WAS PERFORMED ON (B)(6) 2009. IT WAS NOTED THAT HE SUFFERED FROM AN IMPINGEMENT OF HIS SCIATIC NERVE BY HIS LEFT PIRIFORMIS MUSCLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACETABULAR AUGMENT | AUGMENT | LPH | ZIMMER TMT | 60554684 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |