UNK HIP ACETABULAR LINER CERAMIC
Report
- Report Number
- 1818910-2024-12292
- Event Type
- Death
- Date Received
- June 5, 2024
- Date of Event
- December 28, 2022
- Report Date
- June 5, 2024
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT # (B)(4). THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PARK JW, KIM HS, KIM KC, LEE YK, HA YC, KOO KH. A 10- TO 12-YEAR FOLLOW-UP STUDY OF DELTA CERAMIC-ON-CERAMIC TOTAL HIP ARTHROPLASTY. ARCH ORTHOP TRAUMA SURG. 2023 AUG;143(8):5385-5394. DOI: 10.1007/S00402-022-04758-X. EPUB 2023 JAN 3. PMID: 36595032. THERE IS LIMITED INFORMATION REGARDING THE PATIENT'S DEATH AT THIS TIME. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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.
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 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.
THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PARK JW, KIM HS, KIM KC, LEE YK, HA YC, KOO KH. A 10- TO 12-YEAR FOLLOW-UP STUDY OF DELTA CERAMIC-ON-CERAMIC TOTAL HIP ARTHROPLASTY. ARCH ORTHOP TRAUMA SURG. 2023 AUG;143(8):5385-5394. DOI: 10.1007/S00402-022-04758-X. EPUB 2023 JAN 3. PMID: 36595032. OBJECTIVE AND METHODS: AUTHORS PREVIOUSLY REPORTED FIVE-TO-SEVEN-YEAR RESULTS OF TOTAL HIP ARTHROPLASTY (THA) WITH THE USE OF DELTA CERAMIC-ON-CERAMIC (COC) BEARING. THEY CONDUCTED AN EXTENSION STUDY WITH A CT SCAN AT A MINIMUM OF 10 YEARS AFTER SURGERY, DESCRIBED IN THIS CURRENT COMPLAINT. (ADDITIONAL FOLLOW-UP RESULTS WERE DESCRIBED IN A RELATED ARTICLE AND HAVE BEEN ADDRESSED IN (B)(4) FROM MARCH 2009 TO MARCH 2011, 273 PATIENTS (310 HIPS) RECEIVED CEMENTLESS THA WITH DELTA COC BEARING, POROUS-COATED CUP AND HYDROXYAPATITE-COATED STEM. IN THIS EXTENDED STUDY, 252 PATIENTS (144 MEN AND 108 WOMEN¿288 HIPS) WERE FOLLOWED FOR A MEAN OF 10.4 YEARS (10-12) WITH CT SCANS IN 133 HIPS (46.2%, 133/288 HIPS). CLINICAL AND RADIOGRAPHIC EVALUATIONS WERE MADE AT EACH FOLLOW-UP AND KAPLAN-MEIER SURVIVAL ANALYSIS WAS PERFORMED WITH REVISION AND REOPERATION AS ENDPOINTS. ALL PATIENTS RECEIVED DEPUY PINNACLE CUPS AND CORAIL HYDROXYAPATITE-COATED STEMS, AND DEPUY DELTA CERAMIC ACETABULAR LINERS AND CERAMIC FEMORAL HEADS. NO SPECIFIC INDIVIDUAL PRODUCT DETAILS WERE PROVIDED. RESULTS: THERE WERE NO CERAMIC FRACTURES. COMPARED TO MID-TERM RESULTS, THE INCIDENCE OF SQUEAKING AND RADIOLUCENT LINES (RLLS) INCREASED TO 3.1% (9/288) AND 19.4% (56/288), RESPECTIVELY. THE RLL PROGRESSED TO FOCAL OSTEOLYSIS IN 3 HIPS (5.4%, 3/56). NO HIP HAD DETECTABLE WEAR OR PROSTHETIC LOOSENING. TWO HIPS WERE REOPERATED DUE TO PERIPROSTHETIC JOINT INFECTION AND PERIPROSTHETIC FEMORAL FRACTURE IN EACH. IMPLANT SURVIVORSHIP DECREASED TO 98.3% (96.7-99.9%) AT 12 YEARS. CONCLUSION: DURING THE EXTENDED FOLLOW-UP, NO CERAMIC FRACTURE OCCURRED, WHILE THE INCIDENCE OF SQUEAK INCREASED BY 0.7%. THE LONG-TERM SURVIVORSHIP OF DELTA COC THA WAS CONSIDERED TO BE ENCOURAGING. HOWEVER, FOCAL OSTEOLYSIS OCCURRED AROUND THE HYDROXYAPATITE-COATED STEM IN 1% (3/288). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN CORAIL STEM, UNKNOWN PINNACLE CUP, UNKNOWN CERAMIC FEMORAL HEAD, UNKNOWN CERAMIC ACETABULAR LINER ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH UNK CORAIL FEMORAL STEM (QTY 1) CASE #1: A 27-YEAR-OLD FEMALE PATIENT WITH PRE-EXISTING SYSTEMIC LUPUS ERYTHEMATOSUS EXPERIENCED PERIPROSTHETIC JOINT INFECTION 9 YEARS AFTER HER THA. TREATMENT INCLUDED IRRIGATION & DEBRIDEMENT WITH FEMORAL HEAD IMPLANT REVISION. WHILE TREATMENT FOR INFECTION APPEARED TO BE EFFECTIVE, PATIENT DIED FROM MYOCARDITIS ONE MONTH AFTER HER IRRIGATION & DEBRIDEMENT. NRPP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH UNK CERAMIC FEMORAL HEAD (QTY 1) CASE #1: A 27-YEAR-OLD FEMALE PATIENT WITH PRE-EXISTING SYSTEMIC LUPUS ERYTHEMATOSUS EXPERIENCED PERIPROSTHETIC JOINT INFECTION 9 YEARS AFTER HER THA. TREATMENT INCLUDED IRRIGATION & DEBRIDEMENT WITH FEMORAL HEAD IMPLANT REVISION. WHILE TREATMENT FOR INFECTION APPEARED TO BE EFFECTIVE, PATIENT DIED FROM MYOCARDITIS ONE MONTH AFTER HER IRRIGATION & DEBRIDEMENT. NRPP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH UNK CERAMIC ACETABULAR LINER (QTY 1) CASE #1: A 27-YEAR-OLD FEMALE PATIENT WITH PRE-EXISTING SYSTEMIC LUPUS ERYTHEMATOSUS EXPERIENCED PERIPROSTHETIC JOINT INFECTION 9 YEARS AFTER HER THA. TREATMENT INCLUDED IRRIGATION & DEBRIDEMENT WITH FEMORAL HEAD IMPLANT REVISION. WHILE TREATMENT FOR INFECTION APPEARED TO BE EFFECTIVE, PATIENT DIED FROM MYOCARDITIS ONE MONTH AFTER HER IRRIGATION & DEBRIDEMENT. NRPP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH UNK PINNACLE ACETABULAR CUP (QTY 1) CASE #1: A 27-YEAR-OLD FEMALE PATIENT WITH PRE-EXISTING SYSTEMIC LUPUS ERYTHEMATOSUS EXPERIENCED PERIPROSTHETIC JOINT INFECTION 9 YEARS AFTER HER THA. TREATMENT INCLUDED IRRIGATION & DEBRIDEMENT WITH FEMORAL HEAD IMPLANT REVISION. WHILE TREATMENT FOR INFECTION APPEARED TO BE EFFECTIVE, PATIENT DIED FROM MYOCARDITIS ONE MONTH AFTER HER IRRIGATION & DEBRIDEMENT. NRPP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK CORAIL FEMORAL STEM (QTY 1) CASE #2: AN 82-YEAR-OLD FEMALE PATIENT SUSTAINED A DISPLACED PERIPROSTHETIC FEMUR FRACTURE 10 YEARS AFTER HER THA, TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION USING CERCLAGE WIRE FIXATION¿ALL IMPLANTS WERE RETAINED, NRPP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK CORAIL STEM (QTY 27). 2 PATIENTS EXPERIENCED PERIPROSTHETIC FEMUR FRACTURES, TREATED CONSERVATIVELY/NON-OPERATIVELY WITH DAILY SUBCUTANEOUS INJECTION OF TERIPARATIDE MEDICATION¿THIS IS MINOR INJURY FOR BOTH PATIENTS, NRPP. 12 TOTAL HIP ARTHROPLASTIES (THA) DEVELOPED HETEROTOPIC OSSIFICATION, WHICH DID NOT LIMIT PATIENT ACTIVITIES¿NO TREATMENT WAS PROVIDED FOR THIS MINOR INJURY, NRPP. 6 PATIENTS EXPERIENCED THIGH PAIN¿NO TREATMENT WAS PROVIDED FOR THIS MINOR INJURY, NRPP. 4 FEMORAL STEMS WITH REPORTED RADIOLUCENT LINES¿NO TREATMENT PROVIDED, AND NO INFORMATION ASSOCIATED WITH THIS MINOR INJURY. 3 FEMORAL STEM WITH FEMORAL OSTEOLYSIS¿NO TREATMENT PROVIDED FOR THIS MINOR INJURY, NRPP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK PINNACLE ACETABULAR CUP (QTY 12) 12 TOTAL HIP ARTHROPLASTIES (THA) DEVELOPED HETEROTOPIC OSSIFICATION, WHICH DID NOT LIMIT PATIENT ACTIVITIES¿NO TREATMENT WAS PROVIDED FOR THIS MINOR INJURY, NRPP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK CERAMIC LINER (QTY 21) 9 REPORTS OF SQUEAKING. NO TREATMENT PROVIDED AND NO ADDITIONAL INFORMATION FOR THIS MINOR INJURY. 12 TOTAL HIP ARTHROPLASTIES (THA) DEVELOPED HETEROTOPIC OSSIFICATION, WHICH DID NOT LIMIT PATIENT ACTIVITIES¿NO TREATMENT WAS PROVIDED FOR THIS MINOR INJURY, NRPP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK CERAMIC HEAD (QTY 21) 9 REPORTS OF SQUEAKING. NO TREATMENT PROVIDED AND NO ADDITIONAL INFORMATION FOR THIS MINOR INJURY. 12 TOTAL HIP ARTHROPLASTIES (THA) DEVELOPED HETEROTOPIC OSSIFICATION, WHICH DID NOT LIMIT PATIENT ACTIVITIES¿NO TREATMENT WAS PROVIDED FOR THIS MINOR INJURY, NRPP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1296354 | UNK HIP ACETABULAR LINER CERAMIC | CERAMIC ACETABULAR LINER | LPH | DEPUY ORTHOPAEDICS INC US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death| R |