FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN T72 TIBIAL INSERT TRIAL
MDR report key: 1961209
·
Received December 21, 2010
Report
- Report Number
- 2249697-2010-01822
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Date of Event
- November 25, 2010
- Report Date
- November 25, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- NA
- Removal / Correction Number
- 2249697-07/26/10-005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME EVENT AS STRYKER REFERENCE NUMBER (B)(4). THREE ADDITIONAL DEVICES OF THE LOT # PP15, UNKNOWN CAT # WERE ALSO LISTED IN THIS REPORT; DEVICE MANUFACTURE DATE- UNK.
Description of Event or Problem · 1
IT WAS REPORTED THAT THESE T72 TIBIAL INSERT TRIALS FROM USED STOCK DID NOT PASS THE INSPECTION PROTOCOL FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN T72 TIBIAL INSERT TRIAL | INSTRUMENT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | PP15 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |