UNK HIP ACETABULAR CUP PINNACLE
Report
- Report Number
- 1818910-2025-10924
- Event Type
- Malfunction
- Date Received
- June 30, 2025
- Date of Event
- March 28, 2024
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- JDI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. 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 PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: ADDED: B5, D4 (CATALOG), D10 (CONCOMITANT). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CALLARY SA, SHARMA DK, D'APOLLONIO TM, CRITCHLEY O, MERCER G, WILSON C, CAMPBELL DG. WHAT IS THE LONG-TERM WEAR OF A 5-MRAD HIGHLY CROSSLINKED POLYETHYLENE LINER? A 14-YEAR RSA STUDY. CLIN ORTHOP RELAT RES. 2024 OCT 1;482(10):1789-1797. DOI: 10.1097/CORR.0000000000003047. EPUB 2024 MAR 28. PMID: 38546666; PMCID: PMC11419525. OBJECTIVE/METHODS/STUDY DATA: IN THIS STUDY, THE AUTHORS ASKED: (1) IN PATIENTS WHO UNDERWENT THA WITH A 5-MRAD HIGHLY CROSSLINKED POLYETHYLENE LINER, WHAT IS THE WEAR RATE EVALUATED WITH RSA DURING THE FIRST 14 YEARS? (2) DOES THE WEAR RATE DECREASE AFTER 6 YEARS IN SITU? BETWEEN SEPTEMBER 2003 AND JULY 2004, A TOTAL OF 29 PATIENTS (30 HIPS) UNDERWENT PRIMARY THA WERE ENROLLED. PATIENTS WHO WERE NOT ABLE TO COME FOR FOLLOW-UP WERE EXCLUDED FROM THE STUDY, LEAVING 13 PATIENTS (4 MALE AND 9 FEMALE [13 HIPS]; MEAN AGE OF 70 (56-78) YEARS) AVAILABLE AT 14 YEARS OF FOLLOW-UP (MEDIAN 14.1 YEARS [RANGE 13.3 TO 14.5 YEARS]). ALL PATIENTS RECEIVED UNCEMENTED FEMORAL STEMS (CORAIL¿, DEPUY ORTHOPAEDICS INC) WITH 28-MM COBALT-CHROME FEMORAL HEADS USING THE POSTEROLATERAL APPROACH. ALL PATIENTS HAD A STEM WITH A HEMISPHERICAL, POROUS-COATED, METAL-BACKED SHELL (PINNACLE¿, DEPUY ORTHOPAEDICS INC) AND WERE IMPLANTED WITH A CROSSLINKED POLYETHYLENE LINER (MARATHON¿, DEPUY ORTHOPAEDICS INC). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES PINNACLE ACETABULAR COMPONENT OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: DEPUY SYNTHES CORAIL FEMORAL STEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP PINNACLE (QTY 1): - MEDIAN CUP INCLINATION WAS 50º (RANGE 40º TO 65º), AND MEDIAN CUP VERSION WAS 17º (RANGE 9º TO 34º). NO INTERVENTION NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR LINER POLY (QTY 1): - THE MEAN PROXIMAL FEMORAL HEAD PENETRATION (DEFINED AS MOVEMENT FROM 14 YEARS RELATIVE TO BASELINE EXAMINATION RESULTS IN THE FIRST WEEK) AT 14 YEARS WAS 0.350 MM, WHICH WAS AN INCREASE FROM 0.160 MM AT 6 YEARS. SIMILARLY, THE MEAN 2D (0.418 MM) AND 3D FEMORAL HEAD PENETRATION (0.542 MM) AT 14 YEARS WAS INCREASED FROM 6 YEARS (2D: 0.193 MM; 3D: 0.304 MM). THE MEAN PROXIMAL AND 2D AND 3D WEAR RATES BETWEEN 1 AND 14 YEARS WERE 0.019, 0.022, AND 0.025 MM PER YEAR, RESPECTIVELY. NO INTERVENTION NOTED.
ADDITIONAL INFORMATION RECEIVED STATES THAT NONE OF THE 13 PATIENTS HAD BEEN REVISED WHEN THEY ATTENDED RADIOGRAPHIC FOLLOW-UP FOR THIS MANUSCRIPT IN 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1219393 | UNK HIP ACETABULAR CUP PINNACLE | HIP ACETABULAR CUP | JDI | DEPUY ORTHOPAEDICS INC US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNKNOWN HIP FEMORAL CONSTRUCT CORAIL |