OXF TRL BRG W/SLOTS MED 3MM
Report
- Report Number
- 3002806535-2018-00729
- Event Type
- Malfunction
- Date Received
- April 18, 2018
- Date of Event
- March 19, 2018
- Report Date
- March 7, 2019
- Manufacturer
- BIOMET UK LTD.
- Product Code
- HRY
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
ZIMMER BIOMET COMPLAINT (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE QUALITY ENGINEER FOR INVESTIGATION. THE DHR FOR THE INVOLVED PRODUCT HAS BEEN REVIEWED AND DOES NOT SHOW ANY NON-CONFORMITY, REJECTION OR CONCESSION THAT COULD BE RELATED TO THE REPORTED EVENT. THE FRACTURE OF THE OXFORD TIBIAL TRIAL HAS EVIDENCE OF ABNORMAL STRESSES, POTENTIALLY THE USE OF A UP AND DOWN ROCKING MOTION, EXERTED DURING INSERTION OR REMOVAL OF THE BEARING USING THE OXFORD TRIAL TIBIAL BEARING INSERTER/EXTRACTOR. HOWEVER, THE EXACT CAUSE OF FAILURE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.
TRIAL BROKE DURING TRIAL PHASE OF THE SURGERY.
CMP-(B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT A TRIAL BEARING BROKE DURING TRIAL PHASE OF THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 284610 | OXF TRL BRG W/SLOTS MED 3MM | HRY | BIOMET UK LTD. | N/A | ZB140101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |