FDA Adverse Event
Malfunction
Summary report: N
VANGUARD PS TIBIAL BEARING
MDR report key: 2152625
·
Received June 22, 2011
Report
- Report Number
- 3002806535-2011-00096
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 26, 2011
- Report Date
- May 27, 2011
- Manufacturer
- BIOMET UK LTD.
- Product Code
- JWH
- PMA / PMN Number
- K023546
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. EVALUATION CONFIRMED THAT THE INCORRECT SIZE 79 PRODUCT WAS MIS-PACKAGED AND LABELED AS SIZE 71/75. ALL ITEMS ARE ACCOUNTED FOR. NO PRODUCT WAS DISTRIBUTED OR SOLD IN THE UNITED STATES. THIS REPORT FILED (B)(4), 2011.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A KNEE PROCEDURE ON (B)(6), 2011, A VANGUARD TIBIAL BEARING WAS OPENED AND THE ITEM WAS FOUND TO BE A SIZE 79 AS OPPOSED TO SIZE 71/75 THAT WAS STATED ON THE LABEL. A 45 MINUTE DELAY OCCURRED WHILE LOCATING ANOTHER IMPLANT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VANGUARD PS TIBIAL BEARING | JWH | BIOMET UK LTD. | NA | 2254977 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |