FDA Adverse Event
Injury
Summary report: N
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8
MDR report key: 2850384
·
Received November 16, 2012
Report
- Report Number
- 2249697-2012-02390
- Event Type
- Injury
- Date Received
- November 16, 2012
- Date of Event
- October 25, 2012
- Report Date
- October 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
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR DUE TO HOSPITAL POLICY. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADD'L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, THE SURGEON REVISED PT'S RIGHT REJUVENATE HIP DUE TO ELEVATED ION LEVELS, PAIN, AND COLLECTION OF FLUID IN THE JOINT. DURING THE REVISION, METALLOSIS AND FRETTING AT THE NECK/STEM JUNCTION WAS NOTICED ALONG WITH A SIGNIFICANT AMOUNT TISSUE AT THE JOINT.
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 | MJKWKN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |