22.2MM DIA COCR MOD HD STD NK
Received Aug 18, 2014 · Event occurred Feb 5, 2015
Report 0001825034-2014-07135 · MDR key 4017297
Device
Generic name
Prosthesis, Hip
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
163651
Lot number
540640
Product problems
- Fracture
- Naturally Worn
Patient
Not reported
- Bone Fracture(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO IMPLANT WEAR AND/OR FRACTURE; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT UNDERWENT A HIP REVISION ON (B)(6) 2014 DUE TO WEAR. THE MODULAR HEAD WAS REMOVED AND REPLACED.
Additional Manufacturer Narrative
THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES. "
Additional Manufacturer Narrative
THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4).
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION THAT WAS REPORTED IN ERROR ON A PREVIOUS MEDWATCH.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO IMPLANT WEAR AND/OR FRACTURE; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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: "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-07135 & 1825034-2015- 00921).
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A HIP REVISION ON (B)(6) 2014 DUE TO WEAR. THE MODULAR HEAD WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT UNDERWENT ANOTHER REVISION PROCEDURE ON (B)(6) 2015 DUE TO DISLOCATION. THE ACETABULAR CUP, LINER AND HEAD WERE REMOVED AND REPLACED.