SMR HUMERAL EXTENSION + 9 MM
Report
- Report Number
- 3008021110-2019-00002
- Event Type
- Injury
- Date Received
- January 9, 2019
- Date of Event
- December 15, 2018
- Report Date
- June 20, 2019
- Manufacturer
- LIMACORPORATE SPA
- Product Code
- KWS
- PMA / PMN Number
- K110598
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
FROM THE ADDITIONAL INFO RECEIVED BY THE COMPLAINT SOURCE, WE DISCOVER THAT THIS PATIENT HAS HAD MULTIPLE REVISION SURGERIES THAT CAN BE SUMMARIZED AS FOLLOWING: · 1ST LIMA SURGERY ON 27TH OF JUNE 2018 THIS WAS NOT A PRIMARY TOTAL SHOULDER REPLACEMENT FOR THIS PATIENT. PATIENT PREVIOUSLY HAD A FAILED ARTHROPLASTY (COMPETITOR GLENOID AND HUMERAL PROSTHESES) AND THAT A CEMENT SPACER WAS IN-SITU AT TIME OF THIS SURGERY. A CUSTOMIZED GLENOID AND A LONG REVERSE LATERALIZED LINER (CODE #1362.09.120 LOT# 1714976) WERE IMPLANTED AT THAT TIME; · FIRST REVISION SURGERY ON 12TH OF JULY 2018 (LIMA COMPLAINT #247/18) REVISION SURGERY DUE TO PROSTHESIS INSTABILITY. SURGEON TOOK PATIENT BACK TO THEATRE WITH THE ASSISTANCE OF AN EXPERIENCED COLLEAGUE. DURING THIS SURGERY HUMERAL BODY (CODE 1352.20.010, LOT# 1805171) PREVIOUSLY IMPLANTED WAS REMOVED AND THE LONG REVERSE LATERALIZED LINER (CODE 1362.09.120, LOT# 171476) WAS REPLACED WITH A MEDIUM LATERALIZED LINER (1362.09.115 LOT# 1714974). SURGEON CARRIED OUT STABILITY CHECKS AND ROM AND WAS SATISFIED WITH RESULT; · SECOND REVISION SURGERY ON 13TH OF SEPTEMBER 2018 (LIMA COMPLAINT #328/18) REVISION SURGERY DUE TO PROSTHESIS INSTABILITY AND DISLOCATION. SURGEON RETURNED PATIENT IN THEATRE TO REPLACE THE HUMERAL BODY AND MEDIUM LATERALIZED LINER IN-SITU DUE TO INSTABILITY. ON 13TH OF SEPTEMBER 2018, HUMERAL BODY WITH CODE1352.20.010, LOT# 1810776 AND A LONG LATERALIZING LINER WITH CODE 1362.09.120, LOT# 1706551 WERE IMPLANTED. · OPEN REDUCTION ON 22ND OF SEPTEMBER 2018; · OPEN REDUCTION ON 26TH OF SEPTEMBER 2018; · THIRD REVISION SURGERY ON 29TH OF SEPTEMBER 2018 (LIMA COMPLAINT #332/18) REVISION SURGERY DUE TO PROSTHESIS INSTABILITY AND DISLOCATION. SURGEON PERFORMED THIS REVISION SURGERY TO CHANGE TO A 36MM ECCENTRIC GLENOSPHERE AND TO CONSTRAINED LINER. SURGEON EXPOSED JOINT AND PROCEEDED TO REMOVE THE LONG LATERALIZING LINER PREVIOUSLY IMPLANTED ON 13/09/2018 AND HUMERAL BODY. SURGEON REMARKED THAT THE CUSTOM GLENOID PROSTHESIS WAS STILL SOLID. SURGEON IMPLANTED A 36MM ECCENTRIC GLENOSPHERE WITH SCREW AND A RETENTIVE + 6MM REVERSE LINER (CODE 1361.50.020, LOT#1403907); · FOURTH REVISION SURGERY ON 05TH OF NOVEMBER 2018 - LIMA COMPLAINT 358/18 REASON SURGERY DUE TO IMPLANT DISLOCATION/LUXATION. DURING THIS REVISION SURGERY IT WAS EXPLANTED THE RETENTIVE +6MM LINER PREVIOUSLY IMPLANTED AND A NEW RETENTIVE + 6MM LINER WITH CODE 1361.50.020, LOT# 15AT22J WAS IMPLANTED COMBINED WITH AN EXTENSION FOR HUMERAL BODY WITH CODE 1352.15.001, LOT# 1707698; · FIFTH REVISION SURGERY ON 15TH OF DECEMBER 2018 (LIMA COMPLAINT #04/19) - OBJECT OF THIS REPORT. REVISION SURGERY DUE TO INFECTION AND DISLOCATION 4 DAYS AFTER MOBILIZING THE SHOULDER WITHOUT THE SLING. CONVERSION TO HEMI-ARTHROPLASTY USING CTA HEAD; · SIXTH REVISION SURGERY: 13TH OF FEBRUARY 2019 (LIMA COMPLAINT #55/19) REMOVAL OF CTA HEAD PREVIOUSLY IMPLANTED DUE TO INFECTION. CHECK OF DHR: FOCUSING ON COMPLAINT #04/19, ALL THE LOT#S OF THE COMPONENTS INVOLVED WERE CHECKED AND NO ANOMALY WAS FOUND: - ON A TOTAL OF 37 GLENOSPHERES MANUFACTURED WITH LOT# 1403475 STER. 1400096. - ON A TOTAL OF 80 CONNECTORS + SCREW MANUFACTURED WITH LOT# 1813157 STER. 1800266. - ON A TOTAL OF 73 LINERS MANUFACTURED WITH LOT# 15AT22J STER. 1600065. - ON A TOTAL OF 108 HUMERAL BODIES MANUFACTURED WITH LOT# 1707698 STER. 1700273. - ON A TOTAL OF 55 SCREWS MANUFACTURED WITH LOT# 1702434 STER. 1700335. - ON A TOTAL OF 15 SCREWS MANUFACTURED WITH LOT# 1802647 STER. 1800090. - ON A TOTAL OF 17 SCREWS MANUFACTURED WITH LOT# 1505735 STER. 1500173. THEREFORE, WE CAN ENSURE THAT ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS ANALYSIS: EXPLANTS NOT AVAILABLE TO BE RETURNED TO LIMA CORPORATE. DUE TO HOSPITAL POLICIES ANY EXPLANTED ITEMS FROM PATIENTS ARE NOT DECONTAMINATED AND/OR RETURNED TO MANUFACTURER. X-RAYS ANALYSIS: WE RECEIVED SOME X-RAYS TAKEN ON THE 30TH OF NOVEMBER 2018 AND ASKED FOR A MEDICAL CONSULTANT OPINION. FOLLOWING, THE MEDICAL JUDGMENT: "BETTER GIVEN THAT THE SHOULDER IS NOW INFECTED WOULD HAVE BEEN FOR THE SURGEON TO IMPLANT A PROSTALAC PROSTHESIS RATHER THAN A METAL HEMIARTHROPLASTY". OUR MEDICAL EXPERT HAD BEEN ALREADY CONTACTED BEFORE THE CURRENT EVENT REGARDING THIS PATIENT, AND HE STATED THAT PATIENT REVISIONS WERE NOT RELATED TO AN IMPLANT FAILURE; THE MULTIPLE SURGERIES AND THE PROGRESSIVE LOSS OF STABILIZING ROTATOR CUFF CONTRIBUTED TO THE PROLONGED INSTABILITY OF THE JOINT AND TO THE NEED OF MULTIPLE SURGERIES TO STABILIZE IT. IN CONCLUSION, THE EVENT IS NOT PRODUCT RELATED AND IS MORE LIKELY DUE TO MULTIPLE SURGERIES AND TO PATIENT FACTORS. PMS DATA: ACCORDING TO OUR PMS DATA, SMR REVERSE REVISION RATE DUE TO INFECTION IS 0.056%. NONE OF THE CASES WE COULD INVESTIGATE WERE CLASSIFIED AS PRODUCT RELATED. NO CORRECTIVE ACTIONS PLANNED FOR THIS CASE. LIMACORPORATE WILL KEEP MONITORED THE MARKET.
SMR REVERSE REVISION SURGERY DUE TO INFECTION AND DISLOCATION PERFORMED ON THE 15TH OF DECEMBER 2018. DURING THIS SURGERY, A SMR ANATOMIC HEMI PROSTHESIS WITH CTA HEAD WAS IMPLANTED. DURING CURRENT REVISION, THE FOLLOWING COMPONENTS HAVE BEEN REMOVED: - CUSTOM MADE GLENOID CODE 9617.14.474 LOT# 1808464 STER. 1800172. - GLENOSPHERE, CODE 1376.09.031 LOT# 1403475 STER. 1400096. - CONNECTOR+SCREW, CODE 1374.15.310 LOT# 1813157 STER. 1800266. - LINER, CODE 1361.50.020 LOT# 15AT22J STER. 1600065. - EXTENSION FOR HUMERAL BODY, CODE 1352.15.001 LOT# 1707698 STER. 1700273. -SCREW, CODE 8431.15.032 LOT# 1702434 STER. 1700335. -SCREW, CODE 8431.15.030 LOT# 1802647 STER. 1800090. -SCREW, CODE 8431.15.038 LOT# 1505735 STER. 1500173. THIS WAS THE FIFTH REVISION FOR THIS PATIENT. EVENT OCCURRED IN AUSTRALIA.
BY CHECKING THE STERILIZATION CHARTS OF THE LOT#S OF ALL THE COMPONENTS EXPLANTED ON (B)(6) 2018, NO ANOMALY WAS FOUND; THUS, WE CAN STATE THAT THESE COMPONENTS HAD BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL MDR AFTER THE FINAL INVESTIGATION.
"REVSION" SURGERY DUE TO INFECTION AND DISLOCATION PERFORMED ON (B)(6) 2018. DURING REVISION SURGEON CONVERTED TO HEMI WITH CTA HEAD. ACCORDING TO THE INFO REPORTED, THE SURGEON COMMENTED THAT PATIENT'S SHOULDER WAS STABLE AFTER PREVIOUS REVISION DATED (B)(6) 2018 FOR 2 WEEKS AND THE SHOULDER DISLOCATED 4 DAYS AFTER MOBILISING SHOULDER WITHOUT THE SLING. DURING REVISION SURGERY PERFORMED ON (B)(6) 2018 THE FOLLOWING COMPONENTS HAVE BEEN REMOVED: CUSTOM MADE GLENOID, CODE 9617.14.474 LOT# 1808464 STER. 1800172. GLENOSPHERE, CODE 1376.09.031 LOT# 1403475 STER. 1400096. CONNECTOR+SCREW, CODE 1374.15.310 LOT# 1813157 STER. 1800266. LINER, CODE 1361.50.020 LOT# 15AT22J STER. 1600065. EXTENSION FOR HUMERAL BODY, CODE 1352.15.001 LOT# 1707698 STER. 1700273. SCREW, CODE 8431.15.032 LOT# 1702434 STER. 1700335. SCREW, CODE 8431.15.030 LOT# 1802647 STER. 1800090. SCREW, CODE 8431.15.038 LOT# 1505735 STER. 1500173. THIS PATIENT UNDERWENT SEVERAL REVISION SURGERIES PRIOR TO THE ONE PERFORMED ON (B)(6) 2018, WE CAN SUMMARIZE THE EVENTS AS FOLLOWS: 1ST SURGERY PERFORMED ON (B)(6) 2018 NOT A PRIMARY TSR, PATIENT HAD A PREVIOUS FAILED ARTHROPLASTY (NON LIMA IMPLANT, DETAILS UNKNOWN). SMR REVERSE HAD BEEN IMPLANTED DURING THIS SURGERY. 2ND SURGERY PERFORMED ON (B)(6) 2018: REVISION DUE TO JOINT INSTABILITY. 3RD SURGERY PERFORMED ON (B)(6) 2018: REVISION DUE TO JOINT INSTABILITY. OPEN REDUCTION PERFORMED ON (B)(6) 2018. OPEN REDUCTION PERFORMED ON (B)(6) 2018. 4TH SURGERY PERFORMED ON (B)(6) 2018: REVISION SURGERY DUE TO JOINT INSTABILITY AND DISLOCATION. 5TH SURGERY PERFORMED ON (B)(6) 2018: REVISION SURGERY DUE TO DISLOCATION. 6TH SURGERY PERFORMED ON (B)(6) 2018 DUE TO INFECTION AND DISLOCATION. EVENT HAPPENED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23207 | SMR HUMERAL EXTENSION + 9 MM | SMR HUMERAL EXTENSION + 9 MM | KWS | LIMACORPORATE SPA | 1352.15.001 | 1707698 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |