FDA Adverse Event
Injury
Summary report: N
RELIANCE CM CEMENTED HIP #3
MDR report key: 2150519
·
Received June 23, 2011
Report
- Report Number
- 9616680-2011-00414
- Event Type
- Injury
- Date Received
- June 23, 2011
- Date of Event
- May 31, 2011
- Report Date
- May 31, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K936127
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "RELIANCE STEM REMOVED BECAUSE IT WAS LOOSE. THE HEAD, BONE PLUG, CENTRALIZER AND CEMENT WAS ALL REMOVED AND REPLACED WITH BIOMET ARCOS STEM AND MDM LINER. ORIGINAL CUP STAYED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RELIANCE CM CEMENTED HIP #3 | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | 11392202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |