BIOLOX DELTA LNR 36MM 54-56MM
Report
- Report Number
- 3002806535-2021-00327
- Event Type
- Injury
- Date Received
- August 2, 2021
- Date of Event
- October 30, 2019
- Report Date
- March 26, 2025
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LZO
- UDI-DI
- 05019279114160
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICES ARE USED FOR TREATMENT. NO COMPATIBILITY ISSUES WERE NOTED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT A REVIEW OF COMPLAINT HISTORY WAS ASSESSED FOR THREE YEARS PRIOR TO THE NOTIFICATION DATE AND IDENTIFIED (5) TOTAL COMPLAINTS INCLUDING THE INITIATING COMPLAINT FOR ITEM #650-0795. THERE WAS (1) ADDITIONAL COMPLAINT AGAINST THE LOT #3010403 WHICH IS THE INITIATING COMPLAINT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED THE FOLLOWING: THE PATIENT UNDERWENT SPINAL ANESTHESIA, REVEALING SIGNIFICANT METALLOSIS AND A DEGENERATED CERAMIC ACETABULUM LINER WITH A SCRATCHED CERAMIC HEAD. PENETRATION OF THE CERAMIC HEAD CAUSED METALLOSIS, LEADING TO TISSUE DEBRIDEMENT. SIGNIFICANT LYSIS MEDIALLY AND OSTEOLYSIS ALONG THE PROXIMAL FEMUR WERE OBSERVED. THE STEM WAS REMOVED VIA OSTEOTOMY, WITH STABILIZATION USING A CERCLAGE CABLE. A LONGER STEM IS PLANNED FOR A LATER DATE. THE PATIENT WAS CLOSED WITH INTENT TO RETURN FOR FURTHER INTERVENTIONS. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. . TWO PHOTOGRAPHS WERE RECEIVED AND REVIEWED. THE FIRST PHOTOGRAPH CONTAINS WHAT APPEARS TO BE AN EXCEED SHELL WHICH EXHIBITS AN UNKNOWN BLACK MATERIAL ON IT'S POROUS COATED SURFACE AND ADDITIONALLY A LARGE HOLE ADJACENT THE APICAL PLUG HOLE. THE SECOND PHOTOGRAPH SHOWS THE SAME SHELL WITH THE LARGE HOLE ALONG WITH A CERAMIC HEAD AND FEMORAL STEM. THE CERAMIC HEAD APPEARS TO HAVE BLACK MARKS AND THE STEM POROUS AREA ALSO CONTAINS THE AFORE MENTIONED BLACK MATERIAL. THERE WERE NO PHOTOGRAPHS OF THE FRACTURED CERAMIC LINER PROVIDED SO NO FURTHER ASSESSMENT CAN BE MADE ON THE REPORTED FRACTURED CERAMIC LINER.. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH REGARDS TO THE CERAMIC LINER FRACTURE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A3, B4, B6, B7, D2, G1-2, G3, G6, H2, H11. THE FOLLOWING SECTIONS WERE CORRECTED: D2, G1-2. D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. HOWEVER, THIS DEVICE IS CONSIDERED SIMILAR TO (B)(6). G4 - THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K190660. A REVIEW OF COMPLAINT HISTORY WAS ASSESSED FOR THREE YEARS PRIOR TO THE NOTIFICATION DATE AND IDENTIFIED (5) TOTAL COMPLAINTS INCLUDING THE INITIATING COMPLAINT FOR THE ITEM NUMBER. THERE WAS (1) ADDITIONAL COMPLAINT AGAINST THE LOT NUMBER, WHICH IS THE INITIATING COMPLAINT. ADDITIONAL MEDICAL RECORDS REFERENCING X-RAYS HAVE BEEN PROVIDED FOR THE PATIENT BY THE LEGAL TEAM AND WERE REVIEWED BY AN HCP. LEFT THA WITH MARKED ASYMMETRY OF THE PROSTHETIC FEMORAL HEAD WITH RESPECT TO THE ACETABULAR COMPONENT CONSISTENT WITH LINER WEAR. INTERVAL DEVELOPMENT OF ROUNDED MASSES ABOUT THE LEFT HIP SOME SHOWING COARSE PERIPHERAL CALCIFICATION ¿ MAY REPRESENT METAL ON METAL PSEUDOTUMOR. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH REGARDS TO THE CERAMIC LINER FRACTURE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP PROCEDURE ON (B)(6) 2013. SUBSEQUENTLY, WITHIN 3 YEARS THE PATIENT BEGAN EXPERIENCING PAIN IN THE LEFT HIP AND PRESENTED TO PHYSICIAN ON (B)(6) 2019, WHERE X-RAYS WERE TAKEN AND SHOWED THE LINER HAD CRACKED AND THE HEAD WAS WEARING DIRECTLY ON THE SHELL. ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION TO REPLACE THE IMPLANT. DURING THE SURGERY, SIGNIFICANT METALLOSIS WAS NOTED. THE SURGEON WAS UNABLE TO COMPLETE THE SURGERY AT THAT TIME AND PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON (B)(6) 2019 TO COMPLETE THE SURGERY SUCCESSFULLY.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. ASSOCIATED PRODUCTS: MEDICAL PRODUCT: TAPERLOC POR FMRL 13.5X147, CATALOG NO.: 103207, LOT NO.: 200640. MEDICAL PRODUCT: DELTA CERAMIC FEM HD 36/-3MM, CATALOG NO.: 650-0660 , LOT NO.: 3035752. MEDICAL PRODUCT: EXCEED ABT 3HL SHELL 44/56MM , CATALOG NO.: 124456, LOT NO.: 3083090. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
PATIENT UNDERWENT A LEFT HIP PROCEDURE ON (B)(6) 2013. SUBSEQUENTLY, WITHIN 3 YEARS THE PATIENT BEGAN EXPERIENCING PAIN IN THE LEFT HIP AND PRESENTED TO PHYSICIAN ON (B)(6) 2019 WHERE X-RAYS WERE TAKEN AND SHOWED THE LINER HAD CRACKED AND THE HEAD WAS WEARING DIRECTLY ON THE SHELL. ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION TO REPLACE THE IMPLANT. DURING THE SURGERY, SIGNIFICANT METALLOSIS WAS NOTED. THE SURGEON WAS UNABLE TO COMPLETE THE SURGERY AT THAT TIME AND PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON (B)(6) 2019 TO COMPLETE THE SURGERY SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1161088 | BIOLOX DELTA LNR 36MM 54-56MM | BIOLOX DELTA XLW-18 LINER | LZO | BIOMET UK LTD. | N/A | 3010403 | 05019279114160 |
| 1161089 | BIOLOX DELTA LNR 36MM 54-56MM | BIOLOX DELTA XLW-18 LINER | LZO | BIOMET UK LTD. | N/A | 3010403 | 05019279114160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization| R |