FDA Adverse Event
Injury
Summary report: N
SYS 12 26MM 15D DURATN INS P2
MDR report key: 2150526
·
Received June 23, 2011
Report
- Report Number
- 9616680-2011-00411
- Event Type
- Injury
- Date Received
- June 23, 2011
- Date of Event
- May 16, 2011
- Report Date
- June 1, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K903362
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR.# 9616680-2011-00412.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PATIENT HAD A REVISION THA DUE TO AN OSTEOLYSIS ON (B)(6). DURING THE SURGERY, THE SURGEON NOTICED THAT THERE WAS A LOT OF GRANULATION TISSUE (ABOUT 90GM) AROUND THE HIP JOINT. HE REMAINED THE CITATION STEM AND THE VITALOCK TALON SHELL AND REVISED THE HEAD AND INSERT." THE SURGEON REQUESTED A WEAR ANALYSIS ON THE INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYS 12 26MM 15D DURATN INS P2 | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | VKVRA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |