FDA Adverse Event
Injury
Summary report: N
V40 COCR LFIT HEAD 36MM/+5
MDR report key: 2893444
·
Received December 21, 2012
Report
- Report Number
- 2249697-2012-02758
- Event Type
- Injury
- Date Received
- December 21, 2012
- Date of Event
- October 26, 2012
- Report Date
- November 29, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K022077
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD A LEFT ACCOLADE STEM AND HAD METALLOSIS OF THE TRUNNION AND THE HEAD WAS DISASSOCIATED FROM THE STEM. THE SURGEON REPLACED WITH A RESTORATION MODULAR STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V40 COCR LFIT HEAD 36MM/+5 | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | 16551402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other| R |