32MM MOD HEAD COCR -6MM NECK
Report
- Report Number
- 3002806535-2020-00196
- Event Type
- Injury
- Date Received
- April 1, 2020
- Date of Event
- March 10, 2020
- Report Date
- April 24, 2020
- Manufacturer
- BIOMET UK LTD.
- 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
- PHYSICIAN
Narratives
(B)(4). THIS FINAL/FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7,H1, H2, H10. D11: MEDICAL PRODUCT: RINGLOC-X E1 STD 52/32MM, CATALOG #: EP-043252, LOT #: J3719875 MEDICAL PRODUCT: UNKNOWN TAPERLOC #: UNKNOWN, LOT #: 310760 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00197-2. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. TWO ANTEROPOSTERIOR (AP) X-RAYS (ONE IN ADDUCTION AND ONE IN ABDUCTION) WERE PROVIDED WITH CMP-0590201; THE DATE ON WHICH EACH RADIOGRAPH WAS TAKEN HAS NOT BEEN PROVIDED. ONE 3D RECONSTRUCTION OF THE HIP JOINT PROVIDED WITH THE COMPLAINT IS NOT REVIEWED AS PART OF THIS ACTION ITEM. BOTH RADIOGRAPHS SHOW THE FEMORAL HEAD SITTING WITHIN THE ACETABULAR SHELL WHICH SUGGESTS THAT THE RADIOGRAPHS ARE LIKELY TO BE POST-PRIMARY, HOWEVER EXACT DATES OF THESE RADIOGRAPHS ARE REQUIRED TO CONFIRM THIS. THE AP RADIOGRAPH IN ADDUCTION DOES NOT SHOW THE PATIENT FULL PELVIS AND THEREFORE IT DOES NOT HAVE THE NECESSARY BONY LANDMARKS TO DETERMINE THE INCLINATION ANGLE OF THE ACETABULAR COMPONENT. THE USE OF CERCLAGE WIRE AROUND THE FEMUR IS OBSERVED IN BOTH RADIOGRAPHS. A FEATURE IS OBSERVED NEAR THE INFERIOR ASPECT OF THE ACETABULAR SHELL IS OBSERVED IN THE ABDUCTION RADIOGRAPH. IT IS NOT CLEAR IF THIS IS ALSO A CIRCLAGE WIRE TAB. THE PRESENCE OF THESE SUGGEST THAT THE PATIENT MAY HAVE HAD POOR BONE QUALITY OR A HISTORY OF PRIOR BONE FRACTURE. THE ZIMMER BIOMET PRODUCT EXPERIENCE REPORT (ZPER) PROVIDED WITH THE COMPLAINT STATES PREVIOUS PRIMARY SURGERY CAUSING DISLOCATION AS THE CONTRIBUTING CONDITION RELATED TO THE EVENT. IMMEDIATE POST PRIMARY RADIOGRAPHS, WHICH SHOW THE PATIENT FULL PELVIS, ARE REQUIRED IN ORDER TO EVALUATE THE INITIAL SIZE, POSITION AND ALIGNMENT OF THE COMPONENTS. MOREOVER, PROVISION OF PRE REVISION RADIOGRAPH(S) COULD HELP IN CONFIRMATION OF DISLOCATION OF THE FEMORAL HEAD AND/OR LINER. THE MANUFACTURING HISTORY RECORDS (MHRS) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. GIVEN THAT THE LINER WAS REPLACED WITH A HI-WALL LINER, WHILE THE CUP WAS RETAINED, SUGGESTS THAT CUP POSITIONING MAY HAVE BEEN SUBOPTIMAL AND/OR THAT THE PATIENT HAS A DEGREE OF JOINT LAXITY. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THE ITEMS 163667 AND EP-043252. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. RISK ASSESSMENT: HE REPORTED EVENT STATES REVISION DUE TO DISLOCATION. LINE 2.1.2 OF THE RMF DOCUMENTS A HAZARD OF DISLOCATION OR SUBLUXATION, WITH AN ASSOCIATED SEVERITY SCORE OF 4 FOR THE HARM OF DISLOCATION WHICH IS DEFINED IN THE ATTACHED RMR AS RESULTS IN PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE / NECESSITATES SURGICAL INTERVENTION. THE OUTCOME OF THE REPORTED EVENT THEREFORE IS IN LINE WITH THE RMF. IN ORDER TO CALCULATE THE OCCURRENCE RATE, SALES AND COMPLAINT DATA FOR THIS ITEM NUMBER HAVE BEEN OBTAINED, AND ARE ATTACHED FOR A PERIOD OF THE LAST 3 CALENDAR YEARS PRIOR TO EVENT DATE, BEING MARCH 2020 (AS PER REQUIREMENTS OF MIR REPORTING). - SALES (MARCH 2017 ¿ MARCH 2020 INCLUSIVE) = 10823 UNITS - COMPLAINTS SEARCH WAS CONDUCTED FOR EVENTS OCCURRING BETWEEN MARCH 2017 ¿ TO DATE FOR ITEM 163667. - THERE ARE NO FURTHER COMPLAINTS IDENTIFIED FOR THIS ITEM NUMBER OTHER THAN (B)(4).THEREFORE, THE CALCULATED OCCURRENCE RATE IS 1 IN 10,823 OR 0.009%. - THIS IS CONSIDERED AN ACCEPTABLE OCCURRENCE RATE (0.009% IS AN OCCURRENCE SCORE OF 1 REMOTE: <0.01%). AS PER THE RMF WHICH ESTIMATES AN ACCEPTABLE OCCURRENCE RATE OF 2 (RARE 0.01% TO 0.1%). HOWEVER, SINCE THIS COMPLAINT IS A SINGLE OCCURRENCE THE COMPLAINT TRENDING PROCESS WILL CONTINUE TO MONITOR AND TREND OCCURRENCES IN LINE WITH THE ACCEPTABLE OCCURRENCE RATE. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2020-00197-1. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. REFER ACTION ITEM # AI346260: TWO ANTEROPOSTERIOR (AP) X-RAYS (ONE IN ADDUCTION AND ONE IN ABDUCTION) WERE PROVIDED WITH (B)(4), THE DATE ON WHICH EACH RADIOGRAPH WAS TAKEN HAS NOT BEEN PROVIDED. ONE 3D RECONSTRUCTION OF THE HIP JOINT PROVIDED WITH THE COMPLAINT IS NOT REVIEWED AS PART OF THIS ACTION ITEM. BOTH RADIOGRAPHS SHOW THE FEMORAL HEAD SITTING WITHIN THE ACETABULAR SHELL WHICH SUGGESTS THAT THE RADIOGRAPHS ARE LIKELY TO BE POST-PRIMARY, HOWEVER EXACT DATES OF THESE RADIOGRAPHS ARE REQUIRED TO CONFIRM THIS. THE AP RADIOGRAPH IN ADDUCTION DOES NOT SHOW THE PATIENT¿S FULL PELVIS AND THEREFORE IT DOES NOT HAVE THE NECESSARY BONY LANDMARKS TO DETERMINE THE INCLINATION ANGLE OF THE ACETABULAR COMPONENT. THE USE OF CERCLAGE WIRE AROUND THE FEMUR IS OBSERVED IN BOTH RADIOGRAPHS. A FEATURE IS OBSERVED NEAR THE INFERIOR ASPECT OF THE ACETABULAR SHELL IS OBSERVED IN THE ABDUCTION RADIOGRAPH. IT IS NOT CLEAR IF THIS IS ALSO A CIRCLAGE WIRE TAB. THE PRESENCE OF THESE SUGGEST THAT THE PATIENT MAY HAVE HAD POOR BONE QUALITY OR A HISTORY OF PRIOR BONE FRACTURE. THE ZIMMER BIOMET PRODUCT EXPERIENCE REPORT (ZPER) PROVIDED WITH THE COMPLAINT STATES PREVIOUS PRIMARY SURGERY CAUSING DISLOCATION AS THE CONTRIBUTING CONDITION RELATED TO THE EVENT. IMMEDIATE POST PRIMARY RADIOGRAPHS, WHICH SHOW THE PATIENT¿S FULL PELVIS, ARE REQUIRED IN ORDER TO EVALUATE THE INITIAL SIZE, POSITION AND ALIGNMENT OF THE COMPONENTS. MOREOVER, PROVISION OF PRE REVISION RADIOGRAPH(S) COULD HELP IN CONFIRMATION OF DISLOCATION OF THE FEMORAL HEAD AND/OR LINER. PART NUMBERS OF THE FEMORAL STEM AND ACETABULAR SHELL WERE NOT PROVIDED, THEREFORE THE MANUFACTURING HISTORY RECORDS (MHRS) COULD NOT BE RETRIEVED AND CHECKED. THE MANUFACTURING HISTORY RECORDS (MHRS) OF THE MODULAR HEAD AND RINGLOX-X E1 LINER CONFIRM THAT BOTH WERE MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. GIVEN THAT THE LINER WAS REPLACED WITH A HI-WALL LINER, WHILE THE CUP WAS RETAINED, SUGGESTS THAT CUP POSITIONING MAY HAVE BEEN SUBOPTIMAL AND/OR THAT THE PATIENT HAS A DEGREE OF JOINT LAXITY. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THE ITEMS 163667 AND EP-043252. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO DISLOCATION WAS PERFORMED.
THE PATIENT WAS REVISED DUE TO HIP DISLOCATION.
(B)(4). INITIAL REPORT. 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 PRODUCT: RINGLOC-X E1 STD, CATALOG #: EP-043252, LOT #: J3719875. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2020-00197. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.
THE PATIENT WAS REVISED DUE TO HIP DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 376455 | 32MM MOD HEAD COCR -6MM NECK | HIP PROTHESIS | JDI | BIOMET UK LTD. | N/A | J3656007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |