UNK HIP FEMORAL HEAD METAL

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, (01) GTIN IS NOT AVAILABLE.

Description of Event or Problem

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PARK SH, BALL TM, RUPERT M, SANGIORGIO SN, EBRAMZADEH E. FINDINGS FROM 333 RETRIEVED MOM TOTAL HIP ARTHROPLASTY COMPONENTS OF A SINGLE DESIGN REVEAL MODULAR INTERFACE CORROSION AS MOST COMMON FEATURE. J AM ACAD ORTHOP SURG GLOB RES REV. 2026 MAY 26;10(5):E26.00018. DOI: 10.5435/JAAOSGLOBAL-D-26-00018. PMID: 42201794; PMCID: PMC13209496. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY PRESENTS THE LARGEST RETRIEVAL ANALYSIS OF THIS DESIGN, INVESTIGATING RELATIONSHIPS AMONG FEMORAL HEAD AND ACETABULAR LINER TAPER CORROSION, BEARING SURFACE WEAR, AND IMPLANT DESIGN FEATURES. BETWEEN (B)(6) 2013 AND (B)(6) 2023, A TOTAL OF 333 RETRIEVED PINNACLE MOM COMPONENT PAIRS FROM NORTH AMERICA, AUSTRALIA, AND JAPAN CONSISTING OF 333 FEMORAL HEADS, 331 ACETABULAR LINERS, 74 FEMORAL STEMS, AND 67 ACETABULAR SHELLS. OF THE INCLUDED COMPONENTS, 36 WERE FROM PATIENTS WHO WERE REVISED BILATERALLY. TAPER CORROSION WAS ASSESSED USING THE VISUAL GRADING SYSTEM. BEARING SURFACE WEAR AND DIAMETRAL CLEARANCE WERE QUANTIFIED USING COORDINATE MEASURING TECHNIQUES. CORRELATIONS BETWEEN TAPER DAMAGE, BEARING WEAR, CLEARANCE, AND TIME IN VIVO WERE EVALUATED USING NONPARAMETRIC STATISTICAL TESTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES, CERENOVUS, BWI DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES PINNACLE MOM AND FEMORAL STEMS (S-ROM, CORAIL, TRI-LOCK, AML, SUMMIT, REPLICA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP PINNACLE (QTY (B)(4): - 67 ACETABULAR SHELLS WERE RETRIEVED FROM REVISION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR LINER METAL PINNACLE (QTY (B)(4): - 331 ACETABULAR LINERS WERE RETRIEVED FROM REVISION. - 265 LINERS WITH WEAR - 41 LINERS WITH CORROSION - 34 CASES WERE ACCOMPANIED BY TISSUE SUITABLE FOR ASEPTIC LYMPHOCYTIC VASCULITIS-ASSOCIATED LESIONS (ALVAL) SCORING. SCORES RANGED FROM 3 TO 10 (MEDIAN, 6). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL HEAD METAL (QTY (B)(4): - 333 FEMORAL HEADS WERE RETRIEVED FROM REVISION. - 287 FEMORAL HEADS WITH WEAR - 188 HEAD TAPER CORROSION - 34 CASES WERE ACCOMPANIED BY TISSUE SUITABLE FOR ASEPTIC LYMPHOCYTIC VASCULITIS-ASSOCIATED LESIONS (ALVAL) SCORING. SCORES RANGED FROM 3 TO 10 (MEDIAN, 6). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM S-ROM (QTY (B)(4): - 49 STEM LOOSENING AT BONE TO IMPLANT INTERFACE AND 2 TAPER CORROSION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM TRI-LOCK (QTY (B)(4): -2 STEM LOOSENING AT BONE TO IMPLANT INTERFACE AND 2 TAPER CORROSION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM CORAIL (QTY (B)(4): -14 STEM LOOSENING AT BONE TO IMPLANT INTERFACE AND 2 TAPER CORROSION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM AML (QTY (B)(4): -2 STEM LOOSENING AT BONE TO IMPLANT INTERFACE AND 2 TAPER CORROSION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM SUMMIT (QTY (B)(4): -1 STEM LOOSENING AT BONE TO IMPLANT INTERFACE AND 2 TAPER CORROSION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM REPLICA (QTY 1(B)(4): -1 STEM LOOSENING AT BONE TO IMPLANT INTERFACE AND 2 TAPER CORROSION.