FDA Adverse Event
Injury
Summary report: N
OMNIFIT SER. II CUP INS. 0 DEG
MDR report key: 2833014
·
Received October 30, 2012
Report
- Report Number
- 9616680-2012-00970
- Event Type
- Injury
- Date Received
- October 30, 2012
- Date of Event
- October 8, 2012
- Report Date
- October 17, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LPH
- PMA / PMN Number
- K943054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ASSOCIATED DEVICE: C-TAPER COCR LFIT HEAD 28MM/+5, CATALOG # 06-2805, LOT UNK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DISLOCATED. THE SURGEON DECIDED TO REVISE THE POLY AND THOUGHT A CONSTRAINED LINER WOULD BE THE BEST OPTION. THE CASE WENT WELL AND THE NEW CONSTRUCT IS SOLID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIFIT SER. II CUP INS. 0 DEG | IMPLANT | LPH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other| R |