SMR GLENOSPHERE Ø 36MM
Report
- Report Number
- 3008021110-2021-00056
- Event Type
- Injury
- Date Received
- July 22, 2021
- Date of Event
- July 12, 2021
- Report Date
- November 8, 2021
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- KWS
- PMA / PMN Number
- K163397
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2018949, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 37 ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 28 OUT OF 37 GLENOSPHERES WITH LOT #2018949 - STER. 2000330 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #18AT20R - STER. 1800387, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 41 ITEMS MANUFACTURED WITH THE SAME LOT# - STER. ACCORDING TO OUR RECORDS, AT LEAST 23 OUT OF 41 REVERSE LINERS WITH LOT #18AT20R - STER. 1800387 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. EXPLANTED ITEMS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS DATED (B)(6) 2021 REFERRING TO PRE-OPERATIVE REVISION SURGERY OF (B)(6) 2021. LIMACORPORATE ALSO RECEIVED A TOTAL OF THREE X-RAYS - DATED (B)(6) 2021 - REFERRING TO PRE-OPERATIVE REVISION SURGERY OF (B)(6) 2021. ADDITIONALLY, ONE X-RAYS OF THE ORIGINAL HEMI IMPLANT WAS PROVIDED - EXACT DATE NOT KNOWN. ALL AVAILABLE X-RAYS HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING THE MEDICAL CONSULTANT COMMENTS: "FIRST COMMENTS TO MAKE IS AS BEST I CAN TELL THE BASEPLATE IS WELL POSITIONED WITH THE INFERIOR PORTION ALMOST AT THE INFERIOR MARGIN OF THE NATIVE GLENOID. THE TILT IS SLIGHTLY DOWN WHICH IS GOOD. I CANNOT COMMENT ON THE VERSION OF THE HUMERUS BECAUSE THAT IS NOT POSSIBLE ON XRAY. I CANNOT SEE ANY EVIDENCE OF INFERIOR IMPINGEMENT WHICH IS ALSO GOOD BUT DOES NOT EXCLUDE ANTERIOR OR POSTERIOR IMPINGEMENT. IN SUMMARY THE BASEPLATE AND THE HUMERAL COMPONENTS "LOOK SATISFACTORY". I CAN SEE THE ORIGINAL IMPLANT BUT IT DOES NOT APPEAR TO BE CONNECTED TO THE HUMERUS AND POSSIBLY WITH A LATERAL VIEW WE MIGHT SEE IT IS COMPLETELY DETACHED. THE SURGEON WOULD KNOW BUT DOES NOT RECORD THIS. THE SIGNIFICANCE BEING THE HUMERUS WOULD HAVE MIGRATED SUPERIORLY WITH ASSOCIATED CONTRACTURE OF THE SOFT TISSUES MAKING REDUCTION DIFFICULT AS THE SURGEON EXPERIENCED AND NECESSITATING SHORTENING OF THE HUMERUS. THE INITIAL COMPONENTS WERE AS I UNDERSTAND 44MM GLENOSPHERE BUT IT DOES NOT SPECIFY CONCENTRIC OR ECCENTRIC. THIS DISLOCATED AND THE 2ND REVISION IF I UNDERSTAND CORRECTLY WAS TO REIMPLANT THE SAME SIZED COMPONENTS BUT CHANGE THE ROTATION OF THE GLENOSPHERE TO ANTERIOR. I DON'T THINK I WOULD HAVE DONE THAT BUT TRIALLED A LATERALISING HUMERAL IMPLANT. THE LOGIC OF REVISING THIS COMBINATION TO A 36 MM AND RETENTIVE LINER WAS NOT A GOOD OPTION AS PREDICTABLY THIS ALSO DISLOCATED. IT IS NOT MENTIONED BUT SOMETIMES SCARRING INFERIORLY CAN ACT AS A FULCRUM AND BE RESPONSIBLE FOR THE INSTABILITY. IT IS RISKY SURGERY TO DEAL WITH THAT BUT NECESSARY IF PRESENT. I AGREE THIS WAS A DIFFICULT PROBLEM TO DEAL WITH AND THE LOSS OF THE STABILISING ANTERIOR AND POSTERIOR CUFF ATTACHMENTS WILL HAVE SIGNIFICANTLY MADE THE INSTABILITY GREATER". IN CONCLUSION, ACCORDING TO THE MEDICAL EXPERT "[...] A DIFFICULT PROBLEM TO DEAL WITH. I AM CONCERNED ABOUT COMPONENT CHOICES, AND I THINK ASKING ADVICE WOULD HAVE BEEN APPROPRIATE. THAT MAY HAVE HAPPENED? WE DON'T KNOW. IN CONCLUSION I THINK WE HAVE TO SHARE THE REASON FOR FAILURE PARTLY SURGEON BUT PROBABLY MOSTLY PATIENT CAUSE. IT IS NOT "PROSTHESIS" CAUSE!". BASED ON THE PERFORMED ANALYSIS, AND CONSIDERING THAT: · CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOTS #2018949 AND #18AT20R; · ACCORDING TO THE MEDICAL EXPERT, THE REASON FOR FAILURE IS PARTLY SURGEON- AND MOSTLY PATIENT-RELATED; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE IMPLANTS DUE TO DISLOCATION IS 0.14%. 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 OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6) 2021, DUE TO IMPLANT DISLOCATION. IT WAS REPORTED THAT DUE TO PATIENT'S AGE AND POOR ARTHROPLASTY OUTCOME, SURGEON DECIDED TO REMOVE ALL IMPLANTED COMPONENTS: · SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT #2018949 - STER. 2000330). · SMR REVERSE LINER RETENTIVE STD (PRODUCT CODE 1361.50.010, LOT #18AT20R - STER. 1800387) - PRODUCT NOT SOLD IN THE US. · SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2102497 - STER. 2100098). · SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2109550 - STER. 2100164). · SMR UNCEMENTED GLENOID # SMALL (PRODUCT CODE 1375.20.020, LOT #2005927 - STER. 2000192) - PRODUCT NOT SOLD IN THE US. · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2024411 - STER. 2100026). · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2103519 - STER. 2100078). · CEMENTLESS FINNED STEM DIA. 15MM, L. 80MM (PRODUCT CODE 1304.15.150, LOT #2017348 - STER. 2000313). NO COMPONENTS WERE LEFT IN SITU. PATIENT IS A FEMALE, 92 YEARS OLD. PATIENT'S HISTORY OF REVISIONS IS THE FOLLOWING: - PRIMARY IMPLANT OF COMPETITOR'S HEMI PROSTHESIS (EXACT DATE NOT KNOWN) - FIRST REVISION SURGERY (B)(6) 2021, DUE TO PATIENT'S FALL. COMPETITOR'S HEMI PROSTHESIS WAS EXPLANTED AND A SMR REVERSE IMPLANT WAS PLACED IN - SECOND REVISION SURGERY ON (B)(6) 2021, DUE TO DISLOCATION. REMOVAL STEM, REVERSE HUMERAL BODY AND HUMERAL LINER, NEW COMPONENTS PLACED IN. EVENT REGISTERED AS COMPLAINTS #158_21 AND REPORTED TO THE FDA AS MFR # 3008021110-2021-00053. - THIRD REVISION SURGERY ON (B)(6) 2021, DUE TO DISLOCATION. REGISTERED AS COMPLAINT #161_21. IT WAS REPORTED THAT DUE TO PATIENT' SEVERE BONE LOSS AND LACK OF SURGICAL INTERVENTION IN A MORE TIMELY MANNER, A MORE POSITIVE OUTCOME WAS UNABLE TO BE ACHIEVED. EVENT HAPPENED IN AUSTRALIA.
BY CHECKING THE MANUFACTURING CHARTS OF LOT #2018949 AND LOT #18AT20R, NO ANOMALIES WERE DETECTED ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.
SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6) 2021, DUE TO IMPLANT DISLOCATION. IT WAS REPORTED THAT DUE TO PATIENT'S AGE AND POOR ARTHROPLASTY OUTCOME, SURGEON DECIDED TO REMOVE ALL IMPLANTED COMPONENTS: SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT #2018949 - STER. 2000330). SMR REVERSE LINER RETENTIVE STD (PRODUCT CODE 1361.50.010, LOT #18AT20R - STER. 1800387) - PRODUCT NOT SOLD IN THE US. SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2102497 - STER. 2100098). SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2109550 - STER. 2100164). SMR UNCEMENTED GLENOID # SMALL (PRODUCT CODE 1375.20.020, LOT #2005927 - STER. 2000192) - PRODUCT NOT SOLD IN THE US. BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2024411 - STER. 2100026). BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2103519 - STER. 2100078). THE STEM WAS EXPLANTED AS WELL. NO COMPONENTS LEFT IN SITU. PATIENT WILL BE ASSESSED AND MONITORED FOR HER PAIN. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. PATIENT IS A FEMALE, (B)(6) YEARS OLD. THE PATIENT HAS HAD OTHER REVISIONS SINCE THE REMOVAL OF HER HEMIARTHROPLASTY IMPLANT. REVISION SURGERIES WERE REGISTERED AS COMPLAINTS #(B)(4) (REPORTED TO THE FDA AS MFR # 3008021110-2021-00053) AND COMPLAINT #(B)(4). EVENT HAPPENED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1111220 | SMR GLENOSPHERE Ø 36MM | GLENOSPHERE DIA. 36 MM | KWS | LIMACORPORATE S.P.A. | 1374.09.111 | 2018949 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |