ARCOS 15X150MM SPL TPR DIST

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL DEVICES: ZIMMER CAT# 12-115117 CER BIOLOXD MOD HD 32MM +6 NK LOT#2971563; ZIMMER CAT#00223200418 CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH LOT#63688678; ZIMMER CAT#00223200418 CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH LOT#64653320; ZIMMER CAT#00223200418 CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH LOT#64908913; ZIMMER CAT#00223200418 CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH LOT#64908913; ZIMMER CAT#00223200418 CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH LOT#64208911; ZIMMER CAT#00223200418 CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH LOT#63601785; BIOMET CAT#110010263 G7 OSSEOTI MULTIHOLE 50MM D LOT# 3753111. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 02362, 0001825034 - 2021 - 02364.

Description of Event or Problem

IT WAS REPORTED THE PATIENT UNDERWENT REVISION RIGHT TOTAL HIP ARTHROPLASTY APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO STEM SUBSIDENCE AND RECURRENT DISLOCATION. THE SURGEON REPORTED SIGNIFICANT SCARRING AND WAS UNABLE TO DISENGAGE THE PROXIMAL BODY FROM THE STEM. ALL DEVICES WERE REMOVED AND REPLACED EXCEPT FOR THE CUP WHICH REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: H2; H3; H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT UNDERWENT REVISION SURGERY DUE TO STEM SUBSIDENCE AND RECURRENT DISLOCATION. THERE WAS A PAIN USING A WALKER AT TIMES. REPORTS SWELLING, NIGHT PAIN, AND PAIN WITH ACTIVITIES. LIMITED PHYSICAL EXAM DUE TO INSTABILITY AND RISK FOR DISLOCATION, NOTES A HISTORY OF DISLOCATIONS. X-RAYS ¿ HEALING FEMORAL FRACTURE, SUBSIDED MODULAR FEMORAL STEM, GREATER TROCHANTER PROXIMALLY MIGRATED AND RADIOLUCENCY AROUND THE CUP. REMOVED 3 PROXIMAL CABLES AS THEY WERE LOOSE. UNABLE TO DISENGAGE PROXIMAL BODY WITH SLAP HAMMER AND 30MM SUBSIDENCE NOTED. THE FRACTURE SITE WAS NOTED TO BE HEALED, 2 NEW CABLES WERE PLACED. IMAGES NOT SUBMITTED AS ADEQUATE INFORMATION IS PROVIDED IN THE REVISION RECORDS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.