FORTE CER FM HD D28/+3.5 12/14
Report
- Report Number
- 3002806535-2020-00269
- Event Type
- Injury
- Date Received
- June 2, 2020
- Date of Event
- July 22, 2004
- Report Date
- August 13, 2020
- Manufacturer
- .
- Product Code
- JDI
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
(B)(4). G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. IN ERROR THE INCORRECT RISK ASSESSMENT WAS DETAILED IN 3002806535-2020-00269-2. PLEASE SEE THE CORRECT RISK ASSESSMENT BELOW: REASSESSED RISK ASSESSMENT: THE EVENT REPORTS REVISION DUE TO DISLOCATION SUBLUXATION. ALTHOUGH ITEM NUMBER 164127 IS NOW OBSOLETE AND IS NOT INCLUDED IN CURRENT RISK FILES, A RISK MANAGEMENT REPORT HAS BEEN IDENTIFIED WHERE THE RISKS DETAILED IN THE ABOVE FILES ARE EQUIVALENT TO THE RISKS FOR ITEM 164127. THE RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLES COULD NOT BE SELECTED FOR COMPARISON. THE REPORTED EVENT STATES REVISION DUE TO DISLOCATION SUBLUXATION. IN THE ABOVE RISK FILE, DISLOCATION IS CONSIDERED HARM WITH A SEVERITY LEVEL OF 3 FOR A NUMBER OF HAZARDS DEFINED AS MODERATE, WHICH IS DESCRIBED IN THE SEVERITY TABLE AS: S-3 PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. THE OUTCOME OF THIS COMPLAINT (SURGICAL INTERVENTION) IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMR. NO SALES HAVE OCCURRED FOR THIS ITEM NUMBER FOR OVER 3 YEARS PRIOR TO THE NOTIFICATION DATE, THEREFORE AN OCCURRENCE CALCULATION CANNOT BE PERFORMED. IF FURTHER INFORMATION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT IS PROVIDED, RISK SHOULD BE RE-ASSESSED.
(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, H1, H2, H3, H10. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. RISK ASSESSMENT: ALTHOUGH ITEM NUMBER 164127 IS NOW OBSOLETE AND IS NOT INCLUDED IN CURRENT RISK FILES, A RISK MANAGEMENT REPORT HAS BEEN IDENTIFIED WHERE THE RISKS DETAILED IN THESE FILES ARE EQUIVALENT TO THE RISKS FOR ITEM 164127. THE RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLES COULD NOT BE SELECTED FOR COMPARISON. THE REPORTED EVENT STATES REVISION DUE TO DISLOCATION SUBLUXATION. IN THE RISK FILE, DISLOCATION IS CONSIDERED HARM WITH A SEVERITY LEVEL OF 3 FOR A NUMBER OF HAZARDS DEFINED AS MODERATE, WHICH IS DESCRIBED IN THE SEVERITY TABLE AS S-3 PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. THE OUTCOME OF THIS COMPLAINT (SURGICAL INTERVENTION) IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMR. NO SALES HAVE OCCURRED FOR THIS ITEM NUMBER FOR OVER 3 YEARS PRIOR TO THE NOTIFICATION DATE, THEREFORE AN OCCURRENCE CALCULATION CANNOT BE PERFORMED. IF FURTHER INFORMATION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT IS PROVIDED, RISK SHOULD BE RE-ASSESSED.
(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. RESPONSE RECEIVED FROM NJR: NO FURTHER INFORMATION AVAILABLE. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINTS DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS FOR THIS ITEM CODE 164127. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: ITEM NUMBER 164127 IS NOW OBSOLETE, AND IS NO LONGER REFERENCED IN UK RISK FILES. AS A RISK FILE CANNOT BE SELECTED, A RISK ASSESSMENT CANNOT BE CONDUCTED. THIS MATTER WILL BE ESCALATED AT THE COMPLAINTS TRENDING MEETING AS PER SOP163 (DATA TREND ANALYSIS) FOR DETERMINATION OF POTENTIAL FURTHER ACTION. CORRECTIVE ACTION TAKEN: NO CORRECTIVE ACTION REQUIRED AT THIS TIME. PREVENTIVE ACTION TAKEN: NO PREVENTIVE ACTION REQUIRED AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. H3: PRODUCT HAS NOT BEEN RETURNED.
DATA FROM NJR (NATIONAL JOINT REGISTRY - UK) : REVIEW THE PERFORMANCE OF IMPLANTS FOLLOWING A REVIEW OF THE DATA CONDUCTED IN MARCH 2019 ON AURA II, ON 304 PRIMARIES SURGERIES, 33 HAVE BEEN REVISED DURING THE FIRST YEAR POSTOPERATIVE. THIS COMPLAINT IS RELATED TO REVISION DUE TO DISLOCATION SUBLUXATION: IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION (HIP, LEFT), 11 AND HALF YEARS AFTER IMPLANTATION.
DATA FROM NJR ((B)(6)- UK) : REVIEW THE PERFORMANCE OF IMPLANTS FOLLOWING A REVIEW OF THE DATA CONDUCTED IN (B)(6) 2019 ON AURA II, ON 304 PRIMARIES SURGERIES, 33 HAVE BEEN REVISED DURING THE FIRST YEAR POSTOPERATIVE. THIS COMPLAINT IS RELATED TO REVISION DUE TO DISLOCATION SUBLUXATION: IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION (HIP, LEFT), 11 AND HALF YEARS AFTER IMPLANTATION.
DATA FROM NJR (NATIONAL JOINT REGISTRY - UK) : REVIEW THE PERFORMANCE OF IMPLANTS FOLLOWING A REVIEW OF THE DATA CONDUCTED IN (B)(6) 2019 ON AURA II, ON 304 PRIMARIES SURGERIES, 33 HAVE BEEN REVISED DURING THE FIRST YEAR POSTOPERATIVE. THIS COMPLAINT IS RELATED TO REVISION DUE TO DISLOCATION SUBLUXATION: IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION (HIP, LEFT), 11 AND HALF YEARS AFTER IMPLANTATION.
(B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 0 DEGREE TM NATURAL CUP ID 28MM OD 56MM, CATALOG #: 00-7255-056-28, LOT #: 56459007. MEDICAL PRODUCT: TIGE AURA II HAP G T.08, CATALOG #: P0125H08, LOT #: 0000043807. (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
DATA FROM (B)(6): REVIEW THE PERFORMANCE OF IMPLANTS FOLLOWING A REVIEW OF THE DATA CONDUCTED IN (B)(6) 2019 ON AURA II, ON 304 PRIMARIES SURGERIES, 33 HAVE BEEN REVISED DURING THE FIRST YEAR POSTOPERATIVE. THIS COMPLAINT IS RELATED TO REVISION DUE TO DISLOCATION SUBLUXATION: IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION (HIP, LEFT), 11 AND HALF YEARS AFTER IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573384 | FORTE CER FM HD D28/+3.5 12/14 | HIP ARTHROPLASTY | JDI | . | N/A | 692181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |