UNK HIP FEMORAL HEAD CERAMIC
Report
- Report Number
- 1818910-2022-11127
- Event Type
- Injury
- Date Received
- June 17, 2022
- Date of Event
- March 9, 2022
- Report Date
- June 17, 2022
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). 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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION 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. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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 : THE DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON THE VISUAL ANALYSIS OF THE PROVIDED PHOTOGRAPHIC EVIDENCE FOR UNK HIP FEMORAL HEAD CERAMIC, IT CANNOT BE DETERMINATE A DEPUY'S DEVICE FAILURE OR MALFUNCTION WHICH COULD CONTRIBUTE TO REPORTED EVENT. FEMORAL HEAD STILL ENGAGED TO THE CORAIL STEM. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED. SINCE FEMORAL HEAD WAS STILL ENGAGED TO STEM, IT WAS NOT POSSIBLE TO DETERMINE A VALID LOT NUMBER.
ON (B)(6) 2022, A TOTAL HIP REPLACEMENT WAS IMPLANTED AT KSSH BY DR. (B)(6). IN THE COURSE OF THE PROCEDURE, AN INFECTION DEVELOPED, WHICH IS WHY A PROSTHESIS-PRESERVING REVISION WAS PERFORMED ON AND ANTIBIOTIC TREATMENT WAS STARTED. IN CASE OF THERAPY FAILURE THE PATIENT WAS TRANSFERRED TO THE KSW FOR FURTHER TREATMENT ((B)(6) 2022). IT WAS FOUND THAT A PROSTHESIS STEM FOR UNCEMENTED ANCHORAGE HAD BEEN CEMENTED IN. WAS CEMENTED IN. FOR 2 REASONS THIS LEADS TO A PREDICTABLE FAILURE: ON THE ONE HAND BECAUSE THE STEM IS COATED WITH HYDROXYAPATITE, AND SECONDLY BECAUSE THE STEM IS MADE OF TITANIUM. THE HYDROXYAPATITE IS A VERY HARD SUBSTANCE, AND CAN CAUSE MASSIVE ABRASION BY FRICTION UNDER PHYSIOLOGICAL MASSIVE ABRASION OF THE CEMENT DUE TO FRICTION UNDER PHYSIOLOGICAL LOADS. THE HYDROXYAPATITE DISSOLVES OVER THE COURSE OF THE MONTHS, THE CEMENT ANCHORAGE WOULD LOOSEN ACCORDINGLY AND FAIL. TITANIUM SHAFTS ARE KNOWN TO FAIL WHEN CEMENTED IN, EXCEPT IN VERY FEW MODELS, BECAUSE THE ABRASION ON THE SURFACE LEADS TO A CONTINUOUS SURFACE LEADS TO CONTINUOUS OXIDATION AND CORRESPONDING SWELLING OF THE STEM, UNTIL THE CEMENT MANTLE OR THE BONE IS CRACKED. IT WAS THEREFORE DECIDED NOT TO TREAT THE PERIPROSTHETIC INFECTION AGAIN IN A PROSTHESIS-PRESERVING MANNER, WHICH WOULD OTHERWISE HAVE BEEN POSSIBLE. HOWEVER, THE PROSTHESIS CHANGE LED TO FURTHER COMPLICATIONS, WITH IN PARTICULAR A MULTILEVEL FRACTURE OF THE FEMUR. THIS COULD BE REPAIRED WITH AN APPROPRIATELY LONG PROSTHESIS STEM. THE RISKS CONCERNING FURTHER COMPLICATIONS AND IN PARTICULAR FAILURE OF INFECTION TREATMENT CORRELATE WITH THE SIZE OF THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162683 | UNK HIP FEMORAL HEAD CERAMIC | HIP FEMORAL HEAD | JDI | DEPUY ORTHOPAEDICS INC US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention | ALTRX NEUT 36IDX52OD| BONE CEMENT(UNK MANUFACTURER & PRODUCT INFO)| CORAIL2 LAT COXA VARA SIZE 13| PALACOS CEMENT| UNKNOWN HIP ACETABULAR CUP |