OPTIPAC 60 REFOB BONE CMT R-3

Additional Manufacturer Narrative

(B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4) D10: (B)(4), AVENIR, STEM, STANDARD, CEMENTED, 2, TAPER 12/14, LOT: UNK. 010000662, G7 PPS LTD ACET SHELL 50D, LOT: 7406405. 30123604, G7 VIT E HIGH WALL LNR 36MM D, LOT: 65257170. 802203602, ZB 12/14 COCR HD 36MM X +0, LOT: 3103134. G2 ¿ FOREIGN: DENMARK. G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K171540. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT DEVELOPED TROCHANTERIC BURSITIS AND WAS GIVEN A NERVE BLOCK AND PRESCRIBED PAIN MEDICATION AND PHYSICAL THERAPY TWENTY-ONE MONTHS AFTER INITIAL LEFT TOTAL HIP ARTHROPLASTY. TWO YEARS POST INITIAL SURGERY THE EVENT WAS RESOLVED, AND ALL PRODUCTS REMAIN IMPLANTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. THE FOLLOWING SECTION WAS CORRECTED: H6 - COMPONENT CODE. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE REPORTED EVENT BY A HEALTH CARE PROFESSIONAL FOUND THAT BURSITIS IS THE INFLAMMATION OR IRRITATION OF THE BURSAE, TYPICALLY CAUSED BY REPETITIVE MOTION, OVERUSE, AND PRESSURE. IT IS A COMMON CONDITION THAT CAN IMPACT ANY JOINT AND MAY LAST FOR A SHORT DURATION OR YEARS. SYMPTOMS INCLUDE PAIN, TENDERNESS, SWELLING, STIFFNESS, DECREASED MOVEMENT, AND REDNESS AROUND THE AFFECTED JOINT. CONSERVATIVE TREATMENT INCLUDES OTC PAIN RELIEVERS, ANTI-INFLAMMATORIES, REST, ICE, ELEVATION, AND PRESSURE WRAPS. IF THESE FAIL, PHYSICAL THERAPY, ASPIRATION, ARTHROSCOPY, OR STEROID INJECTIONS MAY BE NECESSARY. THE COMPLAINT INDICATES THAT POSTOPERATIVE BURSITIS DEVELOPED AND REQUIRED MEDICAL INTERVENTION. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE DEVICE. THIS IS A LIMITED INVESTIGATION, AS PER PROCEDURE, A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW WILL NOT BE COMPLETED FOR LIMITED INVESTIGATION COMPLAINTS AS THE PRODUCT MEETS THE APPLICABLE ACCEPTANCE CRITERIA. INSUFFICIENT INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. UPON COMPLETION OF THE INVESTIGATION, IT WAS FOUND THAT THE EVENT IS NOT DEVICE RELATED, THUS NOT REPORTABLE.

Description of Event or Problem

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