E1 RINGLOC ACETABULAR LINER 40MM SIZE 26 +3 HI-WALL
Received Sep 29, 2016 · Event occurred Jun 28, 2016
Report 0001825034-2016-03869 · MDR key 5988497
Device
Generic name
Prosthesis, Hip
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
EP-108526
Lot number
856070
Product problems
- Difficult to Insert
- Difficult to Insert
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN INITIAL TOTAL HIP ARTHROPLASTY, THE LINER WOULD NOT SEAT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LINER WITHOUT DELAY.
Additional Manufacturer Narrative
(B)(4). THE REPORTED EVENT IS CONFIRMED. THE VISUAL INSPECTION IDENTIFIED THAT THE LINER HAD SCRATCHES; MATERIAL WAS DEFORMED AROUND THE SCALLOPS AND THE RING GROOVE. THE DAMAGE ON THE PRODUCT IS LIKELY FROM ATTEMPT TO LOCK THE LINER INTO THE SHELL. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. DIMENSIONAL VERIFICATION OF THE LINER SHOWS ALL DIMENSIONS ARE CONFORMING TO PRINT TOLERANCES. A COMPATIBILITY CHECK WAS NOT PERFORMED. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
LINER WOULD NOT LOCK.
Additional Manufacturer Narrative
VISUALLY EXAMINATION OF THE LINER IDENTIFIED SCRATCHES AND MATERIAL DEFORMED AROUND THE SCALLOPS AND THE RING GROOVE. THE DAMAGE ON THE PRODUCT IS LIKELY FROM ATTEMPT TO LOCK THE LINER INTO THE SHELL. DIMENSIONAL VERIFICATION OF THE LINER SHOWS ALL DIMENSIONS ARE CONFORMING TO PRINT TOLERANCES. REVIEW OF THE DHR AND DEVICE DEVIATION HISTORY INCLUDED ON THE COMPLAINT DID NOT REVEAL ANY INDICATIONS THAT ANY OF THE PARTS MIGHT HAVE BEEN OUT OF TOLERANCE WHEN THEY LEFT ZIMMER BIOMET CONTROL. THE LINER DIMENSIONS SHOWED ACCEPTABLE TO PRINT SPECIFICATION. BASE ON THE INVESTIGATION RESULTS PRODUCT LEFT ZIMMER BIOMET CONTROL CONFORMING. ROOT CAUSE CANNOT BE DETERMINED.