SMR GLENOSPHERE Ø36MM SMALL-R
Report
- Report Number
- 3008021110-2023-00012
- Event Type
- Injury
- Date Received
- March 3, 2023
- Date of Event
- September 29, 2022
- Report Date
- May 25, 2023
- Manufacturer
- LIMACORPORATE S.P.A
- Product Code
- PHX
- PMA / PMN Number
- K110598
- 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. LIMA CORPORATE HAS NOT REGISTERED ANY OTHER COMPLAINTS RELATED TO LOTS #1800257, #1800400, #1800327, #1800379, #1900007, #1900003. WE WILL 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 COMPONENTS STERILIZED WITH THOSE LOT #S. LIMA CORPORATE HAS NOT REGISTERED ANY OTHER COMPLAINTS RELATED TO LOTS #1800257, #1800400, #1800327, #1800379, #1900007, #1900003. THEREFORE, WE CAN ENSURE THAT ALL THE PRODUCTS PLACED ON THE MARKET WITH THESE LOTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #'S ASSOCIATED WITH AN INFECTION. X-RAY ANALYSIS NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE REQUESTED FROM THE COMPLAINT SOURCE, HOWEVER THEY WERE NOT AVAILABLE. ONE X-RAY FROM PATIENT ASSESSMENT DATED (B)(6) 2022, WAS PROVIDED. BASED ON THE INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED CONSIDERING THAT: CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON COMPONENTS MANUFACTURED WITH THE INVOLVED STERILIZATION LOT #S. LIMA MEDICAL EXPERT REVIEWED CASE "THIS SEEMS TO BE A TYPICAL CASE OF LOW-GRADE INFECTION. THE RADIOGRAPHS SHOW TYPICAL OSTEOLYTIC LINES MAINLY ON THE GLENOID SIDE. THERE ARE NO SIGNS OF IMPLANT-RELATED ISSUES HERE. INFECTION RATE AFTER RTSA IS A KNOWN PROBLEM AND FREQUENT CAUSE FOR REVISION, THIS IS WELL DOCUMENTED IN THE SCIENTIFIC LITERATURE." PMS ANALYSIS ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO INFECTION IS 0.076%. 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 FINAL REPORT.
SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2022 DUE TO INFECTION. DURING THE REVISION SURGERY, THE COMPONENTS ORIGINALLY IMPLANTED ON (B)(6) 2019 WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. PATIENT WAS SEEN FOR PAIN ON (B)(6) 2022. X-RAYS SHOWED POTENTIAL LOOSENING AND OSTEOLYSIS. ON (B)(6) 2022, THE PREVIOUS BONE SCAN WAS EVALUATED AND SHOWED SIGNS OF INFECTION AND LOOSENING. THE PATIENT WITH SURGEON DECIDED TO PROCEED WITH REMOVING THE LIMA SMR IMPLANT AND IMPLANT AN ANTIBIOTIC SPACER. SURGICAL NOTES HAVE THE FOLLOWING DATA "MURKY FLUID, BONE LOSS, FIBRINOUS TISSUE REMOVAL AND BASEPLATE WAS LOOSE" BOTH SIDES WERE EXPLANTED CLEANED AND CEMENT SPACER WAS PLACED. INFECTIOUS DISEASE EVALUATION WAS COMPLETED ON (B)(6) 2022, AND SHOWED: "CULTURES HAVE ALL BEEN FOUND POSITIVE FOR COAGULASE NEGATIVE STAPHYLOCOCCUS" AND WAS PRESCRIBED MEDICATION FOR THE FINDINGS. LIST OF EXPLANTED COMPONENTS. SMR CEMENTLESS FINNED STEM COMMERCIAL CODE #130415190 - LOT #1810259 - STER. #1800257; SMR REVERSE HUMERAL BODY COMMERCIAL CODE #135215010 - LOT #1818356 -STER. #1800400; SMR REVERSE LINER + 3 MM COMMERCIAL CODE #136050815 - LOT #18AT1SW - STER. #1800327; SMR GLENOID PEG TT SMALL-R #M COMMERCIAL CODE #137514652 - LOT #1816845 - STER. #1800379; SMR GLENOID BASEPLATE SMALL-R COMMERCIAL CODE #137515605 - LOT #1817479 - STER. #1900007; SMR GLENOSPHERE Ø36MM SMALL-R COMMERCIAL CODE #137609025 - LOT #1817953 - STER. #1900003 EVENT HAPPENED IN US.
SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 DUE TO INFECTION. DURING THE REVISION SURGERY, THE COMPONENTS ORIGINALLY IMPLANTED ON (B)(6) 2019 WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. PATIENT WAS SEEN FOR PAIN ON (B)(6) 2022. X-RAYS SHOWED POTENTIAL LOOSENING AND OSTEOLYSIS. (B)(6) 2022, THE PREVIOUS BONE SCAN WAS EVALUATED AND SHOWED SIGNS OF INFECTION AND LOOSENING. THE PATIENT WITH SURGEON DECIDED TO PROCEED WITH REMOVING THE LIMA SMR IMPLANT AND IMPLANT AN ANTIBIOTIC SPACER. SURGICAL NOTES HAVE THE FOLLOWING DATA "MURKY FLUID, BONE LOSS, FIBRINOUS TISSUE REMOVAL AND BASEPLATE WAS LOOSE" BOTH SIDES WERE EXPLANTED CLEANED AND CEMENT SPACER WAS PLACED. INFECTIOUS DISEASE EVALUATION WAS COMPLETED ON (B)(6) 2022, AND SHOWED: "CULTURES HAVE ALL BEEN FOUND POSITIVE FOR COAGULASE NEGATIVE STAPHYLOCOCCUS" AND WAS PRESCRIBED MEDICATION FOR THE FINDINGS. LIST OF EXPLANTED COMPONENTS: SMR CEMENTLESS FINNED STEM/ COMMERCIAL CODE #1304.15.190 - LOT #1810259 - STER. #1800257; SMR REVERSE HUMERAL BODY/ COMMERCIAL CODE #1352.15.010 - LOT #1818356 -STER. #1800400; SMR REVERSE LINER + 3 MM/ COMMERCIAL CODE #1360.50.815 - LOT #18AT1SW - STER. #1800327; SMR GLENOID PEG TT SMALL-R #M/ COMMERCIAL CODE #1375.14.652 - LOT #1816845 - STER. #1800379; SMR GLENOID BASEPLATE SMALL-R/ COMMERCIAL CODE #1375.15.605 - LOT #1817479 - STER. #1900007; SMR GLENOSPHERE Ø36MM SMALL-R/ COMMERCIAL CODE #1376.09.025 - LOT #1817953 - STER. #1900003. EVENT HAPPENED IN US. PATIENT FEMALE BIRTHDAY - (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1870818 | SMR GLENOSPHERE Ø36MM SMALL-R | SMR GLENOSPHERE Ø36MM SMALL-R | PHX | LIMACORPORATE S.P.A | 1376.09.025 | 1817953 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Female | Required Intervention |