FDA Adverse Event
Injury
Summary report: N
ACCOLADE PLUS TMZF HIP STEM #3
MDR report key: 2547779
·
Received April 20, 2012
Report
- Report Number
- 9616680-2012-00291
- Event Type
- Injury
- Date Received
- April 20, 2012
- Date of Event
- November 3, 2011
- Report Date
- March 29, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K994366
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: DESCRIPTION: STD MITCH TRH CP (B)(4), CAT #: MAC-9988-4854, LOT #: FM091750, MANUFACTURER: DEPUY. DESCRIPTION: MITCH TRH MD HD (B)(4), CAT #: MMH-9988-0048, LOT #: FM098379, MANUFACTURER: DEPUY. IT CANNOT BE DETERMINE 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: "RIGHT MOM HIP REPLACEMENT (B)(6) 2010. ONGOING PAIN, METAL ION LEVELS NORMAL, MRI SCAN NORMAL. BECAUSE OF CONTINUED PAIN REVISION PERFORMED (B)(6) 2011. REVISION HIP - METAL ON POLY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE PLUS TMZF HIP STEM #3 | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 32602201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other| R |