SMR SHOULDER
Report
- Report Number
- 3008021110-2021-00092
- Event Type
- Injury
- Date Received
- November 24, 2021
- Date of Event
- November 8, 2021
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- KWS
- UDI-DI
- 08033390002608
- PMA / PMN Number
- K113254
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE LINERS THAT BELONG TO LOT NUMBER 16AT14B, THUS WE CAN STATE THAT THESE COMPONENTS WERE RELEASED ON THE MARKET COMPLIANT TO SPECIFICATIONS. THIS IS THE FIRST AND ONLY COMPLAINT ON THE SAME LOT NUMBER (16AT14B). WE WILL SUBMIT A FINAL MDR AFTER THE CONCLUSION OF THE INVESTIGATIONS.
BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE EXISTING ANOMALY WAS DETECTED ON THE 44 LINERS THAT BELONG TO LOT NUMBER 16AT14B, THUS WE CAN STATE THAT THESE COMPONENTS WERE RELEASED ON THE MARKET COMPLIANT TO SPECIFICATIONS. ACCORDING TO OUR RECORDS, AT LEAST 36 LINERS WITH LOT NUMBER 16AT14B HAVE ALREADY BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT ON THIS LOT NUMBER. THE CUSTOM MADE DEVICE CASE REPORT AND PRODUCTION DOCUMENTS WERE ALSO CHECKED WITHOUT FINDING ANY PRE-EXISTING DEVIATION. THE EXPLANTED LINER WAS NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR ANALYSIS. THE FOLLOWING AVAILABLE RADIOGRAPHS WERE SHARED WITH A MEDICAL CONSULTANT, ASKING FOR A CLINICAL ASSESSMENT: PRE-OPERATIVE X-RAYS TAKEN BEFORE THE PRIMARY SURGERY, PRE-OPERATIVE X-RAYS TAKEN BEFORE THE REVISION SURGERY AND DATED (B)(6) 2020. RADIOGRAPHS REFERRING TO THE SECOND REVISION SURGERY WERE INSTEAD NOT AVAILABLE, THE COMPLAINT SOURCE HOWEVER COMMENTED THAT THEY DID NOT SHOW ANYTHING DUE TO INTERFERENCE OF THE METAL FRAGMENTS. THE MEDICAL EXPERT COMMENTED THE FOLLOWING: "THE FIRST RADIOGRAPH WITHOUT IMPLANT SHOWS A HIGH RIDING HUMERAL HEAD, DECENTERED SUPERIORLY. THIS IS AN INDICATOR FOR POOR SUPRASPINATUS (RC) FUNCTION. THIS CANNOT BE SOLVED WITH AN ATSA, AS THE SURGEON DID. THIS IS PROBABLY THE REASON FOR FAILURE OF THE LINER, ASYMMETRIC EDGE LOAD DUE TO SUPERIOR MIGRATION OF THE HUMERAL HEAD. THIS WILL HAPPEN AGAIN, UNTIL THE PROSTHESIS IS CONVERTED TO A REVERSE. THIS IS A SURGICAL ERROR, NOT AN IMPLANT RELATED ISSUE.". IN CONCLUSION, CONSIDERING THAT: THE CHECK OF THE DEVICE HISTORY RECORD, CONFIRMED THAT THE INVOLVED DEVICES WERE MANUFACTURED UP TO SPECIFICATIONS AND IN LINE WITH THE RELEVANT CHECKS AND TESTS, THE IMPLANTS WERE USED WITH DEVICES FROM A DIFFERENT MANUFACTURER AND COMPATIBILITY OF THIS COMBINATION CANNOT BE CONFIRMED THE ANALYSIS OF THE X-RAYS HIGHLIGHTED POOR SUPRASPINATUS FUNCTION AND ACCORDING TO OUR MEDICAL CONSULTANT, THIS PATIENT SHOULD HAVE BEEN TREATED WITH A REVERSE PROSTHESIS CONFIGURATION, IT APPEARS THAT SURGICAL FACTORS MIGHT HAVE CONTRIBUTED TO THE REPORTED ISSUE. WE CLASSIFY THE EVENT AS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF THE L1 LINERS DUE TO DISASSEMBLY AND/OR BREAKAGE IS ABOUT 0,27%. NO CORRECTIVE ACTION NEEDED FOLLOWING THIS COMPLAINT. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.
BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE LINERS THAT BELONG TO LOT NUMBER 16AT14B, THUS WE CAN STATE THAT THESE COMPONENTS WERE RELEASED ON THE MARKET COMPLIANT TO SPECIFICATIONS. THIS IS THE FIRST AND ONLY COMPLAINT ON THE SAME LOT NUMBER (16AT14B). WE WILL SUBMIT A FINAL MDR AFTER THE CONCLUSION OF THE INVESTIGATIONS.
SHOULDER REVISION SURGERY DUE TO BREAKAGE AND DISSOCIATION OF THE LINER (LINER F.MET.BACK GLEN. STANDARD CODE 137750010 LOT 16AT14B STER. 1600332) FROM THE CUSTOM-MADE METAL BACK GLENOID (CMD 18-1338 GLENOID IMPLANT 961714757 LOT 1903772 STER. 1900089). THE HUMERAL COMPONENTS WERE FROM A DIFFERENT MANUFACTURER. ACCORDING TO THE INFORMATION RECEIVED, INFECTION WAS PRESENT. IT WAS REPORTED THAT, DUE TO LINER DISSOCIATION, THE SCREW HEADS HAD WORN, CAUSING THE IMPOSSIBILITY TO REMOVE THE GLENOID IMPLANT AS IT WAS VERY SECURELY FIXED TO THE BONE. THE SURGEON PUT A CEMENT BALL IN BETWEEN THE JOINT AND LEFT IT. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2021, THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2020. SURGERY ON 9TH NOVEMBER 2020 WAS A REVISION SURGERY DUE TO A SIMILAR ISSUE AND WAS REPORTED TO FDA (3008021110-2020-00119). THE INITIAL SURGERY WAS ON (B)(6) 2019. EVENT OCCURRED IN (B)(6).
SHOULDER REVISION SURGERY DUE TO BREAKAGE AND DISSOCIATION OF THE LINER (LINER F.MET.BACK GLEN.STANDARD CODE 137750010 LOT 16AT14B STER. (B)(4)) FROM THE CUSTOM-MADE METAL BACK GLENOID (CMD 18-1338 GLENOID IMPLANT 961714757 LOT 1903772 STER. (B)(4)). THE REVISION SURGERY TOOK PLACE ON (B)(6) 2021. IT WAS REPORTED THAT THE IMPLANT WAS USED IN COMBINATION WITH A HUMERAL SIDE FORM A DIFFERENT MANUFACTURER. ACCORDING TO THE INFORMATION RECEIVED, INFECTION WAS PRESENT. IT WAS REPORTED THAT, DUE TO LINER DISSOCIATION, THE SCREW HEADS HAD WORN, CAUSING THE IMPOSSIBILITY TO REMOVE THE GLENOID IMPLANT AS IT WAS VERY SECURELY FIXED TO THE BONE. THE SURGEON THEN USED A CEMENT IN BETWEEN THE JOINT AND LEFT THE GLENOID IMPLANT IN PLACE. ACCORDING TO THE FURTHER INFORMATION RECEIVED, AN ADDITIONAL SURGERY WAS SUBSEQUENTLY PERFORMED ABOUT THREE MONTHS LATER, TO REMOVE THE GLENOID COMPONENTS. THE INITIAL SURGERY ON THIS PATIENT WAS PERFORMED ON (B)(6) 2019, THE FIRST REVISION SURGERY OCCURRED ON (B)(6) 2020 AND WAS CAUSED BY A SIMILAR ISSUE (DISASSEMBLY AND BREAKAGE OF THE LINER), IT WAS RECORDED AS COMPLAINT (B)(4) AND REPORTED TO FDA (3008021110-2020-00119). EVENT OCCURRED IN THE UK.
SHOULDER REVISION SURGERY DUE TO BREAKAGE AND DISSOCIATION OF THE LINER (LINER F.MET.BACK GLEN. STANDARD CODE (B)(4) LOT 16AT14B STER. 1600332) FROM THE CUSTOM-MADE METAL BACK GLENOID (CMD 18-1338 GLENOID IMPLANT 961714757 LOT 1903772 STER. 1900089). THE HUMERAL COMPONENTS WERE FROM A DIFFERENT MANUFACTURER. ACCORDING TO THE INFORMATION RECEIVED, INFECTION WAS PRESENT. IT WAS REPORTED THAT, DUE TO LINER DISSOCIATION, THE SCREW HEADS HAD WORN, CAUSING THE IMPOSSIBILITY TO REMOVE THE GLENOID IMPLANT AS IT WAS VERY SECURELY FIXED TO THE BONE. THE SURGEON PUT A CEMENT BALL IN BETWEEN THE JOINT AND LEFT IT. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2021, THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2020. SURGERY ON 9TH NOVEMBER 2020 WAS A REVISION SURGERY DUE TO A SIMILAR ISSUE AND WAS REPORTED TO FDA (3008021110-2020-00119). THE INITIAL SURGERY WAS ON (B)(6) 2019. EVENT OCCURRED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1770030 | SMR SHOULDER | LINER FOR METAL-BACK (UHMWPE) STANDARD | KWS | LIMACORPORATE S.P.A. | LINER | 16AT14B | 08033390002608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |