SMR GLENOSPHERE Ø 36MM
Report
- Report Number
- 3008021110-2022-00138
- Event Type
- Injury
- Date Received
- January 4, 2023
- Date of Event
- November 29, 2022
- Report Date
- May 3, 2023
- 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 STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS STERILIZED WITH THOSE LOT #S. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.
CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL NUMBER. THEREFORE, ALL THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS ANALYSIS THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY THE FOLLOWING INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, BUT IT WAS NOT AVAILABLE: · PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY; · RESULTS FROM SPECIMEN ANALYSIS. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, STATING THAT: · CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS STERILIZED WITH THE INVOLVED LOT #S - STER. · ACCORDING TO THE RECEIVED INFORMATION, PATIENT HAD AN ACUTE DENTAL AND SKIN INFECTION WHICH CONTRIBUTED TO THE EVENT; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE DUE TO INFECTION IS 0.08%. 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 A FINAL MDR.
SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INFECTION. IT WAS REPORTED THAT SAMPLES WERE TAKEN FOR LAB TESTING. SURGEON REPORTED AN ACUTE DENTAL AND SKIN INFECTION FOR THE PATIENT. THE FOLLOWING COMPONENTS WERE REMOVED: SMR REVERSE LINER + 3 MM (PRODUCT CODE 1360.50.015, LOT #20AT01M - STER. 2000096) - PRODUCT NOT SOLD IN THE US. · SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT #1921483 - STER. 2000016). SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2005409 - STER. 2000172). MULTIPLE WASHOUTS WERE PERFORMED AND NEW COMPONENTS WERE PLACED IN. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. PATIENT IS 70 YEARS OLD. EVENT HAPPENED IN NEW ZEALAND.
SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2022, DUE TO INFECTION. IT WAS REPORTED THAT SAMPLES WERE TAKEN FOR LAB TESTING, HOWEVER THE RESULTS FROM SPECIMEN ANALYSIS ARE NOT AVAILABLE. ACCORDING TO THE RECEIVED INFORMATION PATIENT HAD AN ACUTE DENTAL AND SKIN INFECTION WHICH CONTRIBUTED TO THE EVENT. THE FOLLOWING COMPONENTS WERE REMOVED: · SMR REVERSE LINER + 3 MM (PRODUCT CODE 1360.50.015, LOT #20AT01M - STER. 2000096) - PRODUCT NOT SOLD IN THE US. · SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT #1921483 - STER. 2000016). · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2005409 - STER. 2000172). MULTIPLE WASHOUTS WERE PERFORMED, AND NEW COMPONENTS WERE PLACED IN. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2020. PATIENT IS 70 YEARS OLD. EVENT HAPPENED IN NEW ZEALAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1053855 | SMR GLENOSPHERE Ø 36MM | GLENOSPHERE DIA. 36 MM | MBF | LIMACORPORATE S.P.A. | 1374.09.111 | 1921483 | |
| 1178201 | SMR GLENOSPHERE Ø 36MM | GLENOSPHERE DIA. 36 MM | MBF | LIMACORPORATE S.P.A. | 1374.09.111 | 1921483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |