SMR GLENOSPHERE Ø 40MM
Report
- Report Number
- 3008021110-2023-00061
- Event Type
- Injury
- Date Received
- May 31, 2023
- Date of Event
- June 28, 2021
- Report Date
- March 5, 2024
- Manufacturer
- LIMACORPORATE S.P.A
- Product Code
- MBF
- PMA / PMN Number
- K163397
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #'S 20AT586, # 2106904, NO PRE-EXISTING ANOMALY WAS FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #'S. THE INVOLVED IMPLANTS WERE NOT AVAILABLE TO BE RETURNED. POST OPERATIVE X RAYS WERE PROVIDED RELATED TO TWO FURTHER DISLOCATIONS/REVISION SURGERIES AFTER INITIAL SURGERY. THE PROVIDED X RAYS AND ALL OTHER DATA WERE SUBMITTED TO A MEDICAL EXPERT FOR EVALUATION. THE EVALUATION RESULTS STATED THAT "THE INITIAL SURGERY IS COMMENTED TO BE UNREMARKABLE WITH STABLE COMPONENTS. THE FIRST RADIOGRAPH IN YOUR DOCUMENT IS AN OBLIQUE VIEW THAT SHOWS THE FRACTURED GREATER TUBEROSITY FRAGMENT COMPLETELY DISLOCATED AND DETACHED, A BIG CHUNK, ALMOST ALL OF THE METAPHYSIS ONLY 20D AFTER INDEX SURGERY. THE REASON IS UNKNOWN, PROBABLY TRAUMATIC, NO SIGNS FOR IMPLANT RELATED ISSUE HERE; IT IS A COMMON COMPLICATION AFTER RTSA. SECOND REVISION IS APPARENTLY DUE TO INFECTION, AGAIN, ONE COMMON COMPLICATION AFTER RTSA, NO IMPLANT-RELATED ISSUE HERE. ESPECIALLY POSTTRAUMATIC CASES HAVE HIGHER INFECTION RATES. IN (B)(6) 2023 ONE IMPORTANT FACT IS NOTED: "DELTOID ATONY". THAT PROBABLY MEANS THAT THE AXILLARY NERVE IS DAMAGED. THIS IS THE MOST SERIOUS CONCERN IN TERMS OF FUNCTION AND STABILITY. WE DO NOT KNOW WHETHER THE NERVE GOT IMPAIRED DURING THE COURSE OF TREATMENT OR BY THE TRAUMA. SO OVERALL, THIS IS A FATEFUL COURSE OF EVENTS. NO IMPLANT-RELATED PROBLEMS ARE INVOLVED. BASED ON THE INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT; ·THE CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S, ·THE RESULTS OF MEDICAL EVALUATION BY EXPERT STATED NO IMPLANT-RELATED PROBLEMS ARE INVOLVED. WE CAN CONCLUDE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO OUR PMS DATA, WE CAN ESTIMATE THE REVISION RATE OF SMR REVERSE SMR GLENOSPHERE COMMERCIAL CODES 1374/1376.09.XXX - 1374/1376.15.XXX FOR DISLOCATION IS 0.07% THE REVISION RATE FOR REVERSE LINERS POLY, COMMERCIAL CODES 1360.50.XXX + 1361.50.XXX + 1365.50.XXX FOR DISLOCATION IS 0.06% BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS THE FINAL MDR.
CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#'S 20AT586, # 2106904, NO PRE-EXISTING ANOMALY WAS FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT#'S. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETE.
PATIENT ORIGINALLY PRESENTED TO THE SURGEON AFTER TRAUMA TO THE HUMERUS AND THIS CAUSED A FRACTURE. DURING THE INITIAL SHOULDER IMPLANTATION SURGERY ((B)(6) 2021) SURGEON NOTED SIGNIFICANT DAMAGE TO THE HUMERAL HEAD, FRACTURE OF THE GREATER AND LESSER TUBEROSITY, TORN SUPRASPINATUS, AND BICEPS TENDON WAS SIGNIFICANTLY DAMAGED. THE SURGEON NOTES "EVERY EFFORT WAS MADE TO FIX THE ROTATOR CUFF AND THE TUBEROSITY FRAGMENT STABILITY". INITIAL SURGERY - (B)(6) 2021. PATIENT - FEMALE. DATE OF BIRTH - (B)(6) 1950 EVENT HAPPENED IN U.S. EXPLANTED COMPONENTS SMR CEMENTLESS FINNED STEM, COMMERCIAL CODE 1304.15.150 - LOT#2024144 - STER. #2100033. SMR REVERSE HUMERAL BODY, COMMERCIAL CODE 1352.15.010 - LOT #2104650 - STER. #2100125. SMR REVERSE LINER +3MM D.40MM, COMMERCIAL CODE 1365.50.815 - LOT #20AT586 - STER.2100121. SMR GLENOSPHERE Ø 40MM, COMMERCIAL CODE 1374.09.121 - LOT #2106904 - STER. #2100136. SMR SMALL-R CONNECTOR +2, COMMERCIAL CODE 1374.15.312 - LOT #2103111 - STER. #2100104. PATIENT MEDICAL HISTORY. (B)(6) 2021 -EMERGENCY ROOM VISIT AFTER PATIENT REPORTED A FALL ON HER LEFT SIDE HITTING HER LEFT SHOULDER AND FACE RESULTING IN LEFT PROXIMAL HUMERAL FRACTURE. THE EMERGENCY ROOM RECOMMENDED CONSERVATIVE MANAGEMENT AS WELL AS OPHTHALMOLOGY CONSULTATION. (B)(6) 2021, INITIAL SHOULDER SURGERY PERFORMED LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY. SIGNIFICANT DAMAGE TO THE HUMERAL HEAD; IT WAS REMOVED. FRACTURE FRAGMENTS OF THE GREATER AND LESSER TUBEROSITY WERE MOBILIZED AND THE TORN SUPRASPINATUS WAS REPAIRED AS BEST AS POSSIBLE TO THE GREAT TUBEROSITY. IMPLANT WAS PLACED, IT HAD EXCELLENT STABILITY. (B)(6) 2021 FOLLOW UP VISIT - THE PATIENT HAD DISLOCATED THE SHOULDER AND RADIOLOGY REPORT NOTES POSSIBLE FRACTURE OF THE GREATER TUBEROSITY/DISPLACEMENT. (B)(6) 2021 THE PATIENT WAS TAKEN INTO SURGERY TO DO A CLOSED REDUCTION OF THE SHOULDER, AND THIS WAS NOT SUCCESSFUL. THE SURGEON THEN OPENED THE PATIENT TO FIND THAT THE TUBEROSITY HAD PULLED OFF THE BONE. WHEN REPAIRING THE TUBEROSITY SURGEON NOTED THAT IMPLANTS "WERE NOT WELL FIXED" AND HE REVISED THE HUMERAL IMPLANTS. THE SURGERY CONCLUDED WITH NO SIGNS OF INSTABILITY AND GOOD ROM.(OBJECT OF THIS REPORT) (B)(6) 2022 - REMOVAL OF COMPONENTS AND PLACEMENT OF A CEMENT SPACER. THERE DID APPEAR TO BE GROSS PURULENT MATERIAL. DEVITALIZED TISSUE WAS RESECTED, AND CURETTES WERE USE TO DEBRIDE THE BONE. THE HUMERAL AND GLENOID COMPONENTS WERE WELL FIXED BUT REMOVED USING STANDARD TECHNIQUE WITHOUT SIGNIFICANT BONE LOSS. THE WOUND WAS IRRIGATED AND DEBRIDED AGAIN, AND THE CEMENT SPACER WAS PLACED. THIS EVENT WAS REGISTERED AS LIMACORPORATE COMPLAINT (B)(4) AND REPORTED TO FDA AS MFR 3008021110-2023-00053. (B)(6) 2023 -SURGERY REMOVAL OF CEMENT SPACER AND REVERSE ARTHROPLASTY. PREOP DIAGNOSIS OF INSTABILITY, DELTOID ATONY, AND PAIN. CEMENT SPACER REMOVED WITHOUT INCIDENT; REVERSE LATERALIZED TOTAL SHOULDER ARTHROPLASTY COMPONENTS WERE PLACED. (B)(6) 2023, FOLLOW UP VISIT DISLOCATION: PATIENT PRESENTS TODAY WITH A DISLOCATED LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY. SURGEON NOTES THAT "SHE IS AT AN INCREASED RISK OF DISLOCATION BECAUSE OF THE NUMBER OF SURGICAL PROCEDURES, HAS HAD PREVIOUS INFECTION, AND THE FACT SHE IS DEVOID OF A LATERAL TUBEROSITY."
PATIENT ORIGINALLY PRESENTED TO THE SURGEON AFTER TRAUMA TO THE HUMERUS AND THIS CAUSED A FRACTURE. DURING THE INITIAL SHOULDER IMPLANTATION SURGERY (ON (B)(6) 2021) SURGEON NOTED SIGNIFICANT DAMAGE TO THE HUMERAL HEAD, FRACTURE OF THE GREATER AND LESSER TUBEROSITY, TORN SUPRASPINATUS, AND BICEPS TENDON WAS SIGNIFICANTLY DAMAGED. THE SURGEON NOTES "EVERY EFFORT WAS MADE TO FIX THE ROTATOR CUFF AND THE TUBEROSITY FRAGMENT STABILITY". UPON FOLLOW UP VISIT (ON (B)(6) 2021) THE PATIENT HAD DISLOCATED THE SHOULDER AND RADIOLOGY REPORT NOTES POSSIBLE FRACTURE OF THE GREATER TUBEROSITY/DISPLACEMENT. ON (B)(6) 2021 THE PATIENT WAS TAKEN INTO SURGERY TO DO A CLOSED REDUCTION OF THE SHOULDER, AND THIS WAS NOT SUCCESSFUL. THE SURGEON THEN OPENED THE PATIENT TO FIND THAT THE TUBEROSITY HAD PULLED OFF THE BONE. WHEN REPAIRING THE TUBEROSITY SURGEON NOTED THAT IMPLANTS "WERE NOT WELL FIXED" AND HE REVISED THE HUMERAL IMPLANTS. THE SURGERY CONCLUDED WITH NO SIGNS OF INSTABILITY AND GOOD ROM. INITIAL SURGERY: ON (B)(6) 2021, PATIENT: FEMALE, DATE OF BIRTH: ON (B)(6) 1950. EXPLANTED COMPONENTS: SMR CEMENTLESS FINNED STEM, COMMERCIAL CODE 1304.15.150 - LOT#: 2024144 - STER#: 2100033. SMR REVERSE HUMERAL BODY, COMMERCIAL CODE 1352.15.010 - LOT#: 2104650 - STER#: 2100125. SMR REVERSE LINER +3MM D.40MM, COMMERCIAL CODE 1365.50.815 - LOT#: 20AT586 - STER: 2100121. SMR GLENOSPHERE Ø 40MM, COMMERCIAL CODE 1374.09.121 - LOT#: 2106904 - STER#: 2100136. SMR SMALL-R CONNECTOR +2, COMMERCIAL CODE 1374.15.312 - LOT#: 2103111 - STER#: 2100104.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1682722 | SMR GLENOSPHERE Ø 40MM | SMR GLENOSPHERE Ø 40MM | MBF | LIMACORPORATE S.P.A | 1374.09.121 | 2106904 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Required Intervention |