SMR HUMERAL HEAD Ø40 MM
Report
- Report Number
- 3008021110-2022-00119
- Event Type
- Injury
- Date Received
- November 17, 2022
- Date of Event
- August 26, 2021
- Report Date
- February 19, 2024
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- KWT
- PMA / PMN Number
- K100858
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE MANUFACTURING CHARTS WERE CHECKED WITH THE FOLLOWING RESULTS: NO PRE-EXISTING ANOMALY WAS FOUND ON THE 25 ITEMS, BELONGING TO PRODUCT CODE 1322.09.400, LOT NUMBER 1818515 AND STERILIZATION NUMBER 1900049. NO PRE-EXISTING ANOMALY WAS FOUND ON THE 66 ITEMS, BELONGING TO PRODUCT CODE 1330.15.270, LOT NUMBER 1910646, STERILIZATION NUMBER 1900298. NO PRE-EXISTING ANOMALY WAS FOUND ON THE 63 ITEMS, BELONGING TO PRODUCT CODE 1350.15.020, LOT NUMBER 1902748, STERILIZATION NUMBER 1900146. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.
INVESTIGATION THE MANUFACTURING CHARTS WERE CHECKED WITH THE FOLLOWING RESULTS: - NO PRE-EXISTING ANOMALY WAS FOUND ON THE 25 ITEMS, BELONGING TO PRODUCT CODE 1322.09.400, LOT NUMBER 1818515 AND STERILIZATION NUMBER (B)(6) - NO PRE-EXISTING ANOMALY WAS FOUND ON THE 66 ITEMS, BELONGING TO PRODUCT CODE 1330.15.270, LOT NUMBER 1910646, STERILIZATION NUMBER (B)(6) - NO PRE-EXISTING ANOMALY WAS FOUND ON THE 63 ITEMS, BELONGING TO PRODUCT CODE 1350.15.020, LOT NUMBER 1902748, STERILIZATION NUMBER (B)(6). NO X-RAYS NOR EXPLANTS WERE AVAILABLE. HOWEVER, THE WHOLE PATIENT'S HISTORY HAS BEEN SHARED WITH THE MEDICAL EXPERT, ASKING FOR HIS EVALUATION. BASED ON HIS ASSESSMENT: "IN RETROSPECT, ALL SURGERIES SEEM TO BE CARRIED OUT IN A REASONABLE WAY WITH GOOD INTENTIONS AND INDICATIONS. THE FIRST IMPLANTATION FAILED BECAUSE OF TRAUMA, NO FURTHER INFORMATION ABOUT FRACTURE PATTERN AVAILABLE. TO STEP BACK TO CTA SITUATION AND GLENOID BONE GRAFTING IS A COMMON OPTION. TO CONVERT THE HEMI TO RTSA IN A SECOND STAGE IS ALSO A REASONABLE INDICATION, BECAUSE OF LESS EXPECTED PAIN WITH RTSA AND BETTER FUNCTION COMPARED TO HEMI. THE REVISION FOR INFECTION IS A FATEFUL COURSE OF EVENT, A NEGATIVE RISK THAT DID GET REALIZED. THERE IS NO SIGN OF IMPLANT-RELATED FAILURE." THEREFORE, CONSIDERING THAT: - CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED IN THE COMPLAINT, NO PRE-EXISTING ANOMALY WAS FOUND - ACCORDING TO THE INFORMATION RECEIVED BY THE MEDICAL EXPERT, THERE IS NO SIGN OF IMPLANT-RELATED FAILURE WE CAN CONCLUDE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA WITHOUT THE POSSIBILITY TO IDENTIFY WITH CERTAINTY THE REASON OF THE REVISION SURGERY, IT IS IMPOSSIBLE TO CALCULATE THE SPECIFIC REVISION RATE FOR THIS KIND OF EVENT. NO CORRECTIVE ACTION IS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER CASE. THIS IS A FINAL MDR.
SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2021. THE ANATOMIC IMPLANT WAS CONVERTED TO REVERSE. DURING THE REVISION SURGERY THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR HUMERAL HEAD Ø40 MM (PRODUCT CODE 1322.09.400, LOT NUMBER 1818515, STERILIZATION NUMBER 1900049). NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT NUMBER 1910646, STERILIZATION NUMBER 1900298). SMR TRAUMA HUM. BODY # LONG (PRODUCT CODE 1350.15.020, LOT NUMBER 1902748, STERILIZATION NUMBER 1900146). THE PATIENT WAS A FEMALE, 65 YEARS OLD. PATIENT'S CLINICAL HISTORY: PRIMARY SURGERY TOOK PLACE IN 2018, AFTER DISLOCATION/SEPARATION, WITHOUT ANY IMPLANT. THE TOTAL SHOULDER ARTHROPLASTY, USING LIMA IMPLANTS, TOOK PLACE ON (B)(6) 2019. AT THE END OF RECOVERY, THE PATIENT GOT T-BONED IN A CAR ACCIDENT THAT CAUSED FRACTURES OF THE RIGHT SHOULDER AS WELL AS A FROZEN SHOULDER. THE PATIENT WAS FOLLOWED FOR ONE YEAR FOLLOWING ACCIDENT. THE FIRST REVISION SURGERY TOOK PLACE ON (B)(6) 2021, PROBABLY DUE TO CAR ACCIDENT. THIS REVISION WAS REGISTERED WITH THE INTERNAL COMPLAINT (B)(4) AND REPORTED WITH THE MFR 3008021110-2022-000116. THE SECOND REVISION SURGERY TOOK PLACE ON AUGUST 26TH, 2021, HEREBY REPORTED. THE THIRD REVISION SURGERY TOOK PLACE ON (B)(6) 2022, DUE TO INFECTION. THIS REVISION WAS REGISTERED WITH THE INTERNAL COMPLAINT (B)(4) AND REPORTED WITH THE MFR 3008021110-2022-00120. EVENT HAPPENED IN UNITED STATES.
SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2021. THE ANATOMIC IMPLANT WAS CONVERTED TO REVERSE. DURING THE REVISION SURGERY THE FOLLOWING COMPONENTS WERE EXPLANTED: - SMR HUMERAL HEAD Ø40 MM (PRODUCT CODE 1322.09.400, LOT NUMBER 1818515, STERILIZATION NUMBER (B)(6)) - NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT NUMBER 1910646, STERILIZATION NUMBER (B)(6)) - SMR TRAUMA HUM. BODY # LONG (PRODUCT CODE 1350.15.020, LOT NUMBER 1902748, STERILIZATION NUMBER (B)(6)) THE PATIENT WAS A FEMALE, 65 YEARS OLD. PATIENT'S CLINICAL HISTORY: - PRIMARY SURGERY TOOK PLACE IN 2018, AFTER DISLOCATION/SEPARATION, WITHOUT ANY IMPLANT. - THE TOTAL SHOULDER ARTHROPLASTY, USING LIMA IMPLANTS, TOOK PLACE ON (B)(6) 2019. AT THE END OF RECOVERY, THE PATIENT GOT T-BONED IN A CAR ACCIDENT THAT CAUSED FRACTURES OF THE RIGHT SHOULDER AS WELL AS A FROZEN SHOULDER. THE PATIENT WAS FOLLOWED FOR ONE YEAR FOLLOWING ACCIDENT. - THE FIRST REVISION SURGERY TOOK PLACE ON (B)(6) 2021, PROBABLY DUE TO CAR ACCIDENT. THIS REVISION WAS REGISTERED WITH THE INTERNAL COMPLAINT (B)(4) AND REPORTED WITH THE MFR 3008021110-2022-000116 - THE SECOND REVISION SURGERY TOOK PLACE ON (B)(6) 2021, HEREBY REPORTED. - THE THIRD REVISION SURGERY TOOK PLACE ON (B)(6) 2022, DUE TO INFECTION. THIS REVISION WAS REGISTERED WITH THE INTERNAL COMPLAINT 300/22 AND REPORTED WITH THE MFR 3008021110-2022-00120 EVENT HAPPENED IN UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2773563 | SMR HUMERAL HEAD Ø40 MM | SMR SHOULDER SYSTEM - HUMERAL HEADS (COCRMO) DIA.40MM | KWT | LIMACORPORATE S.P.A. | 1322.09.400 | 1818515 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |