FDA Adverse Event
Injury
Summary report: N
UNKNOWN RIGHT REJUVENATE/AGBII HIP
MDR report key: 2821540
·
Received October 24, 2012
Report
- Report Number
- 2249697-2012-02007
- Event Type
- Injury
- Date Received
- October 24, 2012
- Date of Event
- April 1, 2010
- Report Date
- October 8, 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
- MA, 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. AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, HOWEVER BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. 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; PATIENT IS COMPLAINING OF PAIN. PATIENT IS EXPERIENCING LIMPING WHEN WALKING. PATIENT IS REPORTING THAT THE DOCTOR DID BLOOD WORK, X-RAYS AND CAT SCAN. PATIENT IS REPORTING THAT HIS COBALT LEVEL IS HIGH AND THAT THE CAT SCAN IS SHOWING MUSCULAR SWELLING. PATIENT STATES THAT THE DOCTOR WANTS TO PERFORM REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN RIGHT REJUVENATE/AGBII HIP | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other |