SMR CONNECTOR SMALL R
Report
- Report Number
- 3008021110-2020-00065
- Event Type
- Injury
- Date Received
- September 3, 2020
- Date of Event
- August 28, 2020
- Report Date
- April 16, 2021
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- KWS
- PMA / PMN Number
- K110598
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
BY CHECKING THE STERILIZATION CHARTS OF THE LIMA COMPONENTS INVOLVED, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE (B)(4) STEMLESS CORES BELONGING TO LOT# 1814628 - (B)(6), ON THE (B)(4) REVERSE LINERS BELONGING TO LOT# 1511371 - (B)(6), AND ON THE (B)(4) CONNECTORS BELONGING TO LOT# 1812459 - (B)(6), ON THE (B)(4) REVERSE HP GLENOSPHERES BELONGING TO LOT# 1818633 - (B)(6) AND ON THE (B)(4) UNCEMENTED GLENOIDS BELONGING TO LOT# 1819783 - (B)(6) . THEREFORE, WE CAN STATE ALL THE COMPONENTS HAVE BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. X-RAYS ANALYSIS LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS AND ONE CT SCAN REFERRING TO PRE-OP REVISION SURGERY. THE X-RAYS AND THE CT SCAN RECEIVED - EXACT DATE NOT KNOWN - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE PRE-REVISION RADIOGRAPHS SHOW A METALBACK THAT IS IMPLANTED VERY MUCH SUPERIORLY AND NOT WITH MUCH ANGULATION INFERIORLY. THAT IS CERTAINLY SUBOPTIMAL, PROBABLY THE CENTRAL PEG LOST PERFECT ANCHORING AND THE BIOMECHNICAL LOAD IS DIRECTED IN A WAY, THAT PULLS THE INFERIOR PART OF THE METALBACK AWAY FROM THE GLENOID BONE RESULTING IN IMPLANT FAILURE. THE REASON FOR REVISION THEREFORE IS PROCEDURE-RELATED AND NOT IMPLANT-RELATED. INFECTION CANNOT BE CONFIRMED ON RADIOGRAPHS". STATING THAT: - NO PRE-EXISTING ANOMALIES WERE FOUND ON THE STERILIZATION CHARTS OF THE INVOLVED PRODUCTS, - THE MEDICAL CONSULTANT SUGGESTED THAT "THE BIOMECHNICAL LOAD IS DIRECTED IN A WAY THAT PULLS THE INFERIOR PART OF THE METALBACK AWAY FROM THE GLENOID BONE RESULTING IN IMPLANT FAILURE. THE REASON FOR REVISION THEREFORE IS PROCEDURE-RELATED AND NOT IMPLANT-RELATED. INFECTION CANNOT BE CONFIRMED ON RADIOGRAPHS" WE CAN CONCLUDE THAT THE ROOT CAUSE ANALYSIS REVEALED THIS COMPLAINT TO BE MOSTLY SURGICAL FACTOR RELATED. PMS DATA BASED ON OUR PMS DATA, WE CAN ESTIMATE A REVISION RATE OF SHOULDER STEMLESS REVERSE IMPLANTS DUE TO INFECTION OF 0,06%. NO SPECIFIC ACTION FOR THIS CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT. NOTE: THIS IS A FINAL REPORT.
REVISION SURGERY OF A SMR STEMLESS REVERSE IMPLANT DUE TO SUSPECTED INFECTION PERFORMED ON (B)(6) 2020. ACCORDING TO THE RECEIVED INFORMATION, THE BASEPLATE WAS LOOSE. IT WAS REPORTED THAT ALTHOUGH THE STEMLESS CORE WAS WELL FIXED, THE SURGEON WAS UNSATISFIED WITH THE INCLINATION LEVEL AND VERSION, THUS IT WAS REMOVED. THE FOLLOWING COMPONENTS WERE EXPLANTED: · SMR STEMLESS - STEMLESS CORE #S (PRODUCT CODE 1355.14.233, LOT# 1814628 - (B)(6)) - PRODUCT NOT MARKETED IN US. · SMR STEMLESS - REVERSE LINER #M (PRODUCT CODE 1365.09.406, LOT# 1511371 - (B)(6)) - PRODUCT NOT MARKETED IN US. · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT# 1812459 - (B)(6)) · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT# 1818633 - (B)(6)) - PRODUCT NOT MARKETED IN US. · SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT# 1819783 - (B)(6)) - PRODUCT NOT MARKETED IN US. A FEMORAL ALLOGRAFT WAS UTILIZED ON THE AXIOMA BASEPLATE. A STEMMED PROSTHESIS WAS IMPLANTED IN A REVERSE CONFIGURATION. SURGEON RESPONSIBLE FOR THE REVISION IS DIFFERENT FROM THE SURGEON OF THE PREVIOUS SURGERY. IT WAS REPORTED THAT THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2019. ACCORDING TO THE COMPLAINT SOURCE, THE PATIENT WAS EXPERIENCING PAIN 3 WEEKS AFTER ORIGINAL SURGERY AND AFTER A RELATIVELY PAIN-FREE RECOVERY INITIALLY. THE PATIENT IS A FEMALE, 78 YEARS OLD. ACCORDING TO THE REPORTED INFORMATION, THE PATIENT WEIGHTED 89KG AT THE TIME OF THE REVISION SURGERY, HYPERTENSIVE, WITH DIABETES MELLITUS NOT WELL CONTROLLED. EVENT OCCURRED IN AUSTRALIA.
BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED PRODUCTS, NO PRE-EXISTING ANOMALIES WERE FOUND THUS WE CAN STATE THAT ALL THE COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.
REVISION SURGERY ON A SMR STEMLESS IMPLANT DUE TO SUSPECTED INFECTION PERFORMED ON (B)(6) 2020. THE BASEPLATE WAS LOOSE. THE COMPONENTS PREVIOUSLY IMPLANTED ON (B)(6) 2019: SMR STEMLESS - STEML. CORE #S (PRODUCT CODE 1355.14.233, LOT# 1814628 - STER.1800364), SMR STEMLESS - REV. LINER #M (PRODUCT CODE 1365.09.406, LOT# 1511371 - STER.1600035), SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT# 1812459 - STER.1800274) - OF ALL THE EXPLANTED COMPONENTS, THIS IS THE ONLY ITEM SOLD IN THE US. SMR REVERSE HP GLENOSPH. 40 MM (PRODUCT CODE 1374.50.400, LOT# 1818633 - STER.1800395), SMR UNCEMENT. GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT# 1819783 - STER.1900059) WERE EXPLANTED. A FEMORAL ALLOGRAFT WAS UTILIZED ON THE AXIOMA BASEPLATE. A STEMMED PROSTHESIS WAS IMPLANTED IN A REVERSE CONFIGURATION. IT WAS REPORTED THAT ALTHOUGH THE STEMLESS CORE WAS WELL FIXED, THE SURGEON WAS UNSATISFIED WITH THE INCLINATION LEVEL AND VERSION, THUS IT WAS REMOVED. ACCORDING TO THE COMPLAINT SOURCE, THE PATIENT WAS EXPERIENCING PAIN 3 WEEKS AFTER ORIGINAL SURGERY AND AFTER A RELATIVELY PAIN-FREE RECOVERY INITIALLY. THE PATIENT IS A FEMALE, OBESE (B)(6), HYPERTENSIVE, WITH DIABETES MELLITUS NOT WELL CONTROLLED. EVENT HAPPENED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 954609 | SMR CONNECTOR SMALL R | CONNECTOR WITH SCREW SMALL-R | KWS | LIMACORPORATE S.P.A. | 1374.15.305 | 1812459 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |