FDA Adverse Event
Injury
Summary report: N
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8
MDR report key: 2576014
·
Received May 10, 2012
Report
- Report Number
- 2249697-2012-00601
- Event Type
- Injury
- Date Received
- May 10, 2012
- Date of Event
- April 19, 2012
- Report Date
- April 25, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K092561
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE FOLLOWING OTHER KNEE DEVICES WERE ALSO LISTED IN THIS REPORT: LRG TAP PRI MOD NCK 8DEG 34MM, NLV-340800G, (B)(4); 28MM STD LFIT V40 HEAD, CAT# 6260-9-128, LOT# 36268301; RESTORATION ADM X3 INS 28/50, CAT# 1236-2-850, LOT# 35040201; RESTORATION ADM. CUP W/HA, CAT# 1235-2-502, LOT# G3057430. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. AN EVAL OF THE DEVICES CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR DUE TO HOSPITAL POLICY. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD HIP PAIN AND SWELLING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | MJRJ4M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |