FDA Adverse Event
Injury
Summary report: N
MODULAR DUAL MOBILITY INSERT
MDR report key: 2150521
·
Received June 23, 2011
Report
- Report Number
- 9616680-2011-00413
- Event Type
- Injury
- Date Received
- June 23, 2011
- Date of Event
- May 28, 2011
- Report Date
- May 31, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- K103233
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SURGEON COMMENTED THAT PATIENT WAS COMING BACK TO OPERATING ROOM FOR POSSIBLE INFECTION, SURGEON EXCHANGED PARTS AND WASHED OUT HIP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MODULAR DUAL MOBILITY INSERT | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | 36749002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |