FDA Adverse Event
Injury
Summary report: N
MIC TIB TRAY 26MM R
MDR report key: 891372
·
Received August 6, 2007
Report
- Report Number
- 1818910-2007-02328
- Event Type
- Injury
- Date Received
- August 6, 2007
- Date of Event
- July 9, 2007
- Report Date
- July 9, 2007
- Manufacturer
- DEPUY-RAYNHAM / A DIV OF DEPUY ORTHOPAEDICS, INC.
- Product Code
- KYK
- PMA / PMN Number
- K880826
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE AS NO PRODUCT WAS RETURNED. ALTHOUGH THE EXACT ROOT CAUSE COULD NOT BE DETERMINED, IT WOULD NOT BE UNREASONABLE TO EXPECT SOME WEAR AFTER APPROX. 15 YEARS OF IMPLANTATION. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THE PRODUCT CODES PROVIDED ARE OBSOLETE ITEMS.
Description of Event or Problem · 1
THE PT WAS REVISED BECAUSE OF POLY WEAR AND METALOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIC TIB TRAY 26MM R | 87KYK | KYK | DEPUY-RAYNHAM / A DIV OF DEPUY ORTHOPAEDICS, INC. | NA | A65X7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA YR | Required Intervention |