FDA Adverse Event
Injury
Summary report: N
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7
MDR report key: 2711523
·
Received August 16, 2012
Report
- Report Number
- 2249697-2012-01292
- Event Type
- Injury
- Date Received
- August 16, 2012
- Date of Event
- July 28, 2012
- Report Date
- July 28, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS
- Product Code
- JDI
- PMA / PMN Number
- K071082
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT #NLV-300800Y, LOT # 26794102, DESCRIPTION: REJUVENATE MODULAR NECK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S EXPERIENCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, PT WAS EXPERIENCING HIP PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 | IMPLANTED | JDI | STRYKER ORTHOPAEDICS | NA | P4KMJE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other| R |