RESTORATION GAP II ACET SHELL
Report
- Report Number
- 0002249697-2013-02087
- Event Type
- Injury
- Date Received
- June 26, 2013
- Date of Event
- June 18, 2013
- Report Date
- June 18, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LZO
- PMA / PMN Number
- K980774
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
AN EVENT REGARDING FRACTURE INVOLVING A RESTORATION GAP CUP WAS REPORTED. THE EVENT WAS CONFIRMED. A MATERIAL ANALYSIS INDICATED THE DEVICE FRACTURED IN FATIGUE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED. A DEVICE HISTORY REVIEW RECORDS INDICATE THE DEVICE WAS MANUFACTURED WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION IS NEEDED FOR A FULL EVALUATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.
REVISION SURGERY. SURGEON REMOVED A BROKEN GAP CUP II IMPLANT WITH CEMENTED CONTEMPORARY CUP AND SCREWS AND REPLACED IT WITH A LINK CAGE AND CEMENTED CONTEMPORARY CUP.
REVISION SURGERY. SURGEON REMOVED A BROKEN GAP CUP II IMPLANT WITH CEMENTED CONTEMPORARY CUP AND SCREWS AND REPLACED IT WITH A LINK CAGE AND CEMENTED CONTEMPORARY CUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290691 | RESTORATION GAP II ACET SHELL | IMPLANT | LZO | STRYKER ORTHOPAEDICS-MAHWAH | 22249 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |