E1 RINGLOC ACETABULAR LINER 36MM SIZE 23
Received Nov 10, 2016 · Event occurred Nov 10, 2015
Report 0001825034-2016-04652 · MDR key 6094413
Device
Generic name
Prosthesis, Hip
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
EP-108223
Lot number
882880
Product problems
- Material Erosion
- Fracture
- Material Erosion
- Fracture
Patient
Not reported
- Pain
- Reaction
- Pain
- Reaction
Narrative
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - BIOMET TAPERLOC FEMORAL STEM CATALOG#: 51-109070 LOT#: 3023608.
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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, AND/OR EXCESSIVE WEIGHT." NUMBER 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2016-00830 AND 1825034-2016-04651 / 04653).
Description of Event or Problem
PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY 19 MONTHS POST-IMPLANTATION DUE TO PAIN, FRACTURED LOCKING RING, FRACTURED LINER, AND THE HEAD WEARING THROUGH THE LINER, CREATING METALLOSIS AND GREY TISSUE/FLUID THAT HAD TO BE REMOVED.
Additional Manufacturer Narrative
CONCOMITANT MEDICAL PRODUCTS: 36MM COCR MOD HD STD CAT: 11-363662 LOT: 619500; RNGLC+ LTD HOLE FIN SHL SZ52 CAT: 16-104152 LOT: 122080; TLOC 133 MP SP T1 PPS HO 7X99 CAT: 51-109070 LOT: 3023608. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.