CER BIOLOXD OPTION HD 28MM
Report
- Report Number
- 3002806535-2020-00542
- Event Type
- Injury
- Date Received
- December 17, 2020
- Date of Event
- December 2, 2020
- Report Date
- April 28, 2021
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LPH
- UDI-DI
- 00887868271373
- PMA / PMN Number
- K200959
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PROCESSING UNIT FOR INVESTIGATION. NO ROOT CAUSE CAN BE IDENTIFIED AS THE COMPLAINT HAS NOT BEEN CONFIRMED, THE VISUAL INSPECTION SHOWS THE HEAD IS STILL LOCATED IN THE VIVACIT-E DM BEARING 28X46MM THEREFORE IT IS UNLIKELY TO HAVE CAUSED THE DISLOCATION, HOWEVER THIS CANNOT BE CONFIRMED WITH THE INFORMATION PROVIDED. VISUAL INSPECTION OF THE CER BIOLOXD OPTION HD 28MM (ITEM: 650-1055 LOT: 2964312) SHOWS MARKS WHERE METALLIC OBJECTS HAVE COME INTO CONTACT WITH THE CERAMIC, THESE MARKS ARE SUPERFICIAL AND MOST LIKELY CAUSED BY THE INSTRUMENTS USED DURING THE REVISION, THERE IS ALSO A DEEP SERRATED INDENT ON THE CER OPTION TYPE 1 TPR SLEEVE +6 IS MANUFACTURED FROM TITANIUM TIA16V4 WHICH IS EASILY MARKED AND HAS MOST LIKELY BEEN DAMAGED BY INSTRUMENT DURING SURGERY. RISK ASSESSMENT: HAZARDOUS SITUATION: HEAD DOES NOT PERFORM AS EXPECTED. EFFECT ON PATIENT: DISLOCATION. THE SEVERITY ASSOCIATED WITH THE ABOVE LINE IS 3. THIS GIVES A SEVERITY SCORE OF S-3 (MODERATE) AS PER THE RMR. THE ACTUAL SEVERITY SCORE IS 3 (MODERATE) IN LINE WITH THE RISK TABLE. OCCURRENCE RATE ASSESSMENT: (B)(6) 2017 TO (B)(6) 2020: (B)(4) ITEMS SOLD. COMPLAINT HISTORY REVIEW: 1. PART NUMBER REVIEW (650-1055): NUMBER OF SIMILAR COMPLAINTS IDENTIFIED: 15 (INCLUDING INITIATING COMPLAINT). 2. LOT NUMBER REVIEW (2964312): NUMBER OF SIMILAR COMPLAINTS IDENTIFIED: 2 (INCLUDING INITIATING COMPLAINT). OCCURRENCE RATIO: 1:1910. RISK SCORE: SEVERITY 3 X OCCURRENCE 3 = 9 (MEDIUM RISK). RISK ASSESSMENT SUMMARY: THE SEVERITY OF THE REPORTED EVENT AND CALCULATED OCCURRENCE FOR SIMILAR COMPLAINTS ARE IN LINE WITH THE RISK FILE THE OVERALL SCORE IS MEDIUM RISK. NO CORRECTIVE OR PREVENTIVE ACTION IS CONSIDERED NECESSARY AT THIS TIME. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). THIS FINAL FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PROCESSING UNIT FOR INVESTIGATION. IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2020 BY DR. (B)(6), USING DUAL MOBILITY CONSTRUCT. IT WAS LATER DETERMINED THAT THE PATIENT EXPERIENCED AN INTRA ARTICULAR DISLOCATION (INNER HEAD DISASSOCIATED FROM OUTER HEAD) TO THE BEST OF MY UNDERSTANDING THE ASSEMBLY OF THE IMPLANT WAS DONE CORRECTLY ACCORDING TO THE SURGICAL TECHNIQUE AND VERIFIED BY THE SURGEON. NO ADDITIONAL INFORMATION, HEAD AND BEARING WERE REVISED ON (B)(6) 2020. ROOT CAUSE OF THE DISASSOCIATION CANNOT BE DETERMINED BUT SUPPLIED PHOTOGRAPHS CLEARLY SHOW THE DISASSOCIATION OF THE COMPONENTS. THE CERAMIC HEAD CER BIOLOXD OPTION HD 28MM (ITEM: 650-1055, LOT: 2964312) CANNOT BE DIMENSIONALLY INSPECTED BECAUSE WE ARE UNABLE TO DISASSEMBLE THE HEAD FROM THE VIVACIT-E DM BEARING 28X46MM. A VISUAL INSPECTION OF THE CERAMIC HEAD CER BIOLOXD OPTION HD 28MM (ITEM: 650-1055, LOT: 2964312) SHOWS NO OBVIOUS REASONS WHY THE DISASSOCIATION TOOK PLACE. A REVIEW OF THE COMPLAINTS DATABASE SHOWS THAT WE HAVE RECEIVED 14 REPORTED EVENTS FOR "DISLOCATION" FOR THE SAME ITEM NUMBER: ¿650-1055 PRIOR TO THE REPORTED EVENT. THE SEVERITY OF THE REPORTED EVENT AND CALCULATED OCCURRENCE FOR SIMILAR COMPLAINTS ARE IN LINE WITH THE RISK FILE THE OVERALL SCORE IS MEDIUM RISK. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION IS CONSIDERED NECESSARY AT THIS TIME. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY USING DUAL MOBILITY CONSTRUCTION ON (B)(6) 2020. IT WAS LATER DETERMINED THAT THE PATIENT EXPERIENCED AN INTRA ARTICULAR DISLOCATION (INNER HEAD DISASSOCIATED FROM OUTER HEAD). IT IS THE CUSTOMERS UNDERSTANDING THE ASSEMBLY OF THE IMPLANT WAS DONE CORRECTLY ACCORDING TO THE SURGICAL TECHNIQUE AND VERIFIED BY THE SURGEON. HEAD AND BEARING REVISED ON (B)(6) 2020.
IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY USING DUAL MOBILITY CONSTRUCTION ON (B)(6) 2020. IT WAS LATER DETERMINED THAT THE PATIENT EXPERIENCED AN INTRA ARTICULAR DISLOCATION (INNER HEAD DISASSOCIATED FROM OUTER HEAD). IT IS THE CUSTOMERS UNDERSTANDING THE ASSEMBLY OF THE IMPLANT WAS DONE CORRECTLY ACCORDING TO THE SURGICAL TECHNIQUE AND VERIFIED BY THE SURGEON. HEAD AND BEARING REVISED ON (B)(6) 2020.
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: ASSOCIATED ITEM 110031013, LOT 64782702, ITEM NAME: VIVACIT-E DM BEARING 28X46MM. ASSOCIATED ITEM NUMBER 650-1068, LOT 2959203, ITEM NAME: CER OPTION TYPE 1 TPR SLEVE +6. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY USING DUAL MOBILITY CONSTRUCTION ON (B)(6) 2020. IT WAS LATER DETERMINED THAT THE PATIENT EXPERIENCED AN INTRA ARTICULAR DISLOCATION (INNER HEAD DISASSOCIATED FROM OUTER HEAD). IT IS THE CUSTOMERS UNDERSTANDING THE ASSEMBLY OF THE IMPLANT WAS DONE CORRECTLY ACCORDING TO THE SURGICAL TECHNIQUE AND VERIFIED BY THE SURGEON. HEAD AND BEARING REVISED ON (B)(6) 2020.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1493602 | CER BIOLOXD OPTION HD 28MM | CERAMIC FEMORAL HEAD PROSTHESIS | LPH | BIOMET UK LTD. | N/A | 2964312 | 00887868271373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | SEE H10. |