FDA Adverse Event
Injury
Summary report: N
LEFT HIP REJUVENATE STEM
MDR report key: 2885198
·
Received December 17, 2012
Report
- Report Number
- 2249697-2012-02702
- Event Type
- Injury
- Date Received
- December 17, 2012
- Date of Event
- May 24, 2012
- Report Date
- November 29, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
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 BROKE HIP IN (B)(6) 2012. PATIENT WAS EXPERIENCING EXTREME PAIN. PATIENT HAD A REVISION WITH A NON-STRYKER HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEFT HIP REJUVENATE STEM | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |