UNK HIP ACETABULAR CUP PINNACLE

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. H3, H6: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SINGH G, CHAN PH, WINSTON B, PUTNAM D, FASIG BH, PAXTON EW, ROYSE KE, INCIDENCE OF LINER DISSOCIATION AND ALL-CAUSE REVISION WITH UNCEMENTED ACETABULAR COMPONENTS IN PRIMARY TOTAL HIP ARTHROPLASTY, THE JOURNAL OF ARTHROPLASTY (2025), DOI: HTTPS://DOI.ORG/10.1016/ J.ARTH.2025.10.019. OBJECTIVE/METHODS/STUDY DATA: THE PRIMARY OBJECTIVES WERE TO DETERMINE THE INCIDENCE OF ACETABULAR LINER DISSOCIATION ASSOCIATED WITH THE MOST UTILIZED IMPLANT WITH HXLPE LINERS WITHIN A LARGE U.S. BASED JOINT REGISTRY AND TO COMPARE THESE RATES WITH OTHER COMMONLY USED MODULAR ACETABULAR SYSTEMS. PATIENTS AGED 18 YEARS AND OLDER WHO UNDERWENT PRIMARY THA FOR OSTEOARTHRITIS WITH A UNIPOLAR ACETABULAR COMPONENT AND HXLPE LINER WERE IDENTIFIED BETWEEN JANUARY 1, 2009 AND DECEMBER 31, 2022. ALL-CAUSE REVISION INCIDENCE AT 13-YEAR FOLLOW-UP WAS 5.9% FOR GROUP ONE, 3.2% FOR GROUP THREE, 4.2% FOR GROUP FOUR, 5.5% FOR GROUP FIVE, AND 7.7% FOR GROUP SIX; IT WAS 2.7% FOR GROUP TWO AT EIGHT YEARS DUE TO SHORTER FOLLOW-UP. THE INCIDENCE OF REVISION DUE TO LINER DISSOCIATION AT 13-YEAR FOLLOW-UP WAS 0.04% FOR GROUP ONE, 0.25% FOR GROUP THREE, 0.0% FOR GROUP FOUR, 0.15% FOR GROUP FIVE, AND 0.32% FOR GROUP SIX; IT WAS 0.01% AT EIGHT YEARS FOR GROUP TWO. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: PINNACLE, ALTRX, AND MARATHON ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CONSTRUCT PINNACLE (QTY: 1504) N=1504 ALL-CAUSE REVISION - REVISIONS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR CUP PINNACLE (QTY: 60) N=60 DISSOCIATION ¿ REVISION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR LINER (QTY: 1) N=1 DISSOCIATION - REVISION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR LINER (QTY: 1) N=1 DISSOCIATION - REVISION.