SMR REVERSE HUMERAL BODY SHORT
Report
- Report Number
- 3008021110-2019-00036
- Event Type
- Injury
- Date Received
- April 5, 2019
- Date of Event
- March 23, 2019
- Report Date
- October 1, 2019
- Manufacturer
- LIMACORPORATE SPA
- Product Code
- KWS
- PMA / PMN Number
- K110598
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
BY CHECKING THE DHR OF THE INVOLVED LOT#S NO PRE - EXISTING ANOMALY WAS FOUND: - ON A TOTAL OF 80 LINERS MANUFACTURED WITH LOT #1819867; - ON A TOTAL OF 63 HUMERAL BODIES MANUFACTURED WITH LOT #1817981; - ON A TOTAL OF 35 STEMS MANUFACTURED WITH LOT #1815333. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED WITH THESE LOT #S. WE RECEIVED PRE-OPERATIVE XRAYS AND SENT THEM TO OUR MEDICAL EXPERT FOR A CLINICAL OPINION. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.
BY CHECKING THE DHR OF THE INVOLVED LOT#S NO PRE - EXISTING ANOMALY WAS FOUND: ON A TOTAL OF 63 HUMERAL BODIES MANUFACTURED WITH LOT# 1817981; ON A TOTAL OF 35 STEMS MANUFACTURED WITH LOT# 1815333. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED WITH THESE LOTS. X-RAYS ANALYSIS: WE RECEIVED SOME X-RAYS DATED (B)(6) 2019 AND SENT THEM TO OUR MEDICAL CONSULTANT FOR A CLINICAL OPINION (EVEN IMAGES WERE OF BAD QUALITY). TO OUR QUESTION ON THE POSSIBILITY OF SURGICAL FACTOR AS POSSIBLE ROOT CAUSE OF DISLOCATION. HE COULD ONLY COMMENT: "THERE IS A VERY ODD METALLIC COMPONENT ASSOCIATED WITH THE GLENOID THAT IS ORIENTATED ROUGHLY TRANSVERSELY AND EXTENDING OUT THE BACK OF THE NATIVE GLENOID POSTERIORLY. I ASSUME IT IS THE PEG OF AN AXIOMA? I AM UNABLE TO COMMENT FURTHER WITHOUT BETTER IMAGING BUT I SUSPECT YOU ARE RIGHT." MOREOVER, WHEN OUR MEDICAL CONSULTANT ANALYZED X-RAYS RELATED TO PREVIOUS REVISION SURGERY, HE COMMENTED: "FROM MY OWN EXPERIENCE WITH MASSIVE BONE DEFECTS IT IS POSSIBLE TO FIX A BASEPLATE WITH ALMOST NO GLENOID BONE (THE DEFECT DOES HAVE TO BE GRAFTED). SO THE FIX THE GLENOID BASEPLATE INITIALLY IS THE SECURITY OF THE SCREWS AND NOT OSSEO-INTEGRATION. THAT COMES LATER. IF THERE WAS GLENOID BONE DEFICIT AT THE FIRST REVISION THEN AUGMENTATION WITH BONE GRAFT WOULD BE APPROPRIATE. AT THE SECOND REVISION SIMILARLY IF THERE WAS BONE DEFICIT, BUT DEPENDING ON THE DEGREE OF DEFICIT THEN POSSIBLY EVEN A CUSTOM GLENOID MIGHT BE INDICATED. THE BASEPLATE SHOULD ALWAYS BE PLACED IN THE CORRECT POSITION AND NOT AS A PLAN IN A HIGHER POSITION. [..] IT IS NOT NORMAL PRACTICE TO SITE THE BASEPLATE HIGHER." ALTHOUGH THIS STATEMENT REFERS TO PREVIOUS SURGERY, IT WAS PREDICTIVE OF SUBSEQUENT DISLOCATION. INDEED, OUR MEDICAL CONSULTANT STATED THAT THE METAL BACK BASEPLATE SHOULD NEVER BE PLACED HIGHER THAN THE CORRECT POSITION, SUGGESTING THAT IN THIS CASE A CUSTOM IMPLANT WOULD HAVE BEEN INDICATED ("AT THE SECOND REVISION SIMILARLY IF THERE WAS BONE DEFICIT, BUT DEPENDING ON THE DEGREE OF DEFICIT THEN POSSIBLY EVEN A CUSTOM GLENOID MIGHT BE INDICATED. THE BASEPLATE SHOULD ALWAYS BE PLACED IN THE CORRECT POSITION AND NOT AS A PLAN IN A HIGHER POSITION.") IN CONCLUSION, BASED ON THE CHECK OF THE MANUFACTURING CHARTS AND ON THE OPINION OF OUR MEDICAL CONSULTANT, WE CAN SPECULATE THAT THIS EVENT WAS MAINLY DUE TO SUBOPTIMAL SURGICAL CHOICES. EVENT NOT PRODUCT- RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, WW SMR REVERSE REVISION RATE DUE TO JOINT DISLOCATION/LUXATION/INSTABILITY IS 0.14%. NO SPECIFIC CORRECTIVE ACTION FOR THIS CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET.
FOLLOW-UP REPORT DUE TO WRONG CODES/LOT#S REPORTED AS EXPLANTED (LATERALIZED MEDIUM LINER 44MM COD #1362.09.115 LOT #1804713; REVERSE HUMERAL BODY SHORT COD #1352.15.005 LOT #1816260; FINNED STEM 12MM COD #1304.15.120 LOT #1500641) IN THE INITIAL MDR; ON CONTRAST, THESE CODES/LOT#S INDICATED THE IMPLANTED PARTS. THE COMPONENTS EXPLANTED DURING CURRENT REVISION SURGERY ARE THE FOLLOWING: - 1362.09.010 SMR REVERSE HP LINER SHORT LOT #1819867 STER.1900049 - 1352.15.005 SMR REVERSE HUMERAL BODY SHORT LOT #1817981 STER.1900015 - 1304.15.140 SMR CEMENTLESS FINNED STEM LOT #1815333 STER.1800352 EVENT DESCRIPTION: REVISION SURGERY DUE TO SHOULDER DISLOCATION OCCURRED ON (B)(6) 2019. PREVIOUS SURGERY OCCURRED ON (B)(6) 2019 WAS ALSO A REVISION (MFR 3008021110-2019-00035) AND WAS DUE TO LOOSENING OF THE METAL BACK. DURING THE FIRST REVISION, SURGEON DECIDED TO IMPLANT THE GLENOID HIGH TO IMPROVE THE STABILITY OF THE IMPLANT BECAUSE OF THE BETTER BONE QUALITY. HOWEVER, THE IMPLANT DISLOCATED AND SURGEON DECIDED TO EXCHANGE FOR LATERALIZED LINER WITH NEW STEM AND BODY. ACCORDING TO THE INFO RECEIVED BY THE COMPLAINT SOURCE, GLENOID COMPONENTS WERE STABLE AND WELL FIXED AND SURGEON DECIDED TO LEAVE THEM IN SITU. SURGEON COMMENTED THAT PATIENT DID NOT RECALL PARTICULAR MOVEMENT OR EVENT THAT RESULTED IN DISLOCATION. SURGEON ALSO MENTIONED THAT PATIENT IS AN ALCOHOLIC AND THIS MAY CONTRIBUTE TO WHY SHE DOESN'T RECALL PARTICULAR EVENT OF DISLOCATION. EVENT OCCURRED IN AUSTRALIA.
REVISION SURGERY DUE TO SHOULDER DISLOCATION OCCURRED ON (B)(6) 2019. LONG CLINICAL PATIENT'S HISTORY CAN BE SUMMARIZED AS FOLLOW: PRIMARY SURGERY: DATE AND EXACT COMPONENTS IMPLANTED UNKNOWN; FIRST REVISION SURGERY ON (B)(6) 2018: CONVERSION FROM ANATOMIC TO REVERSE SHOULDER PROSTHESIS DUE TO LOOSENING OF THE METAL BACK GLENOID PREVIOUSLY IMPLANTED. SURGEON COMMENTED THAT PATIENT'S BONE QUALITY ON THE INFERIOR GLENOID WAS POOR, SO PLANNED TO POSITION THE METAL BACK BASEPLATE A LITTLE HIGHER WHERE THE BONE WAS BETTER IN QUALITY AND ABLE TO SUPPORT A METAL BACK GLENOID; SECOND REVISION SURGERY ON (B)(6) 2019 (TGA REF. #(B)(4)): REVISION SURGERY DUE TO LOOSENING OF THE METAL BACK GLENOID. SURGEON DECIDED TO IMPLANT THE GLENOID METAL BACK HIGH TO IMPROVE THE STABILITY OF THE IMPLANT BECAUSE OF THE BETTER BONE QUALITY. THIRD REVISION SURGERY ON (B)(6) 2019: OPEN LEFT SHOULDER REDUCTION DUE TO DISLOCATION. SURGEON PERFORMED OPEN REDUCTION AND MANAGED TO SUCCESSFUL REDUCE THE SHOULDER AND COMMENTED THAT IT WAS STABLE AND NO COMPONENTS NEEDED TO BE CHANGED. HOWEVER, THE IMPLANT DISLOCATED AND SURGEON DECIDED TO EXCHANGE FOR LATERALIZING THE LINER WITH NEW STEM AND HUMERAL BODY (FOURTH REVISION SURGERY - OBJECT OF THE CURRENT REPORT). ACCORDING TO THE INFO RECEIVED BY THE COMPLAINT SOURCE, GLENOID COMPONENTS WERE STABLE AND WELL FIXED AND SURGEON DECIDED TO LEAVE THEM IN SITU. THE FOLLOWING COMPONENTS WERE EXPLANTED DURING THIS ADDITIONAL REVISION SURGERY: SMR REVERSE HP LINER SHORT NOT MARKED IN USA 1352.15.005, SMR REVERSE HUMERAL BODY SHORT, LOT #1817981, STER.1900015. 1304.15.140, SMR CEMENTLESS FINNED STEM, LOT #1815333, STER.1800352. SURGEON COMMENTED THAT PATIENT DID NOT RECALL PARTICULAR MOVEMENT OR EVENT THAT COULD HAVE RESULTED IN A SHOULDER DISLOCATION. SURGEON ALSO MENTIONED THAT PATIENT IS AN ALCOHOLIC AND THIS MAY HAVE CONTRIBUTED TO WHY PATIENT DOES NOT RECALL ANY PARTICULAR ROOT CAUSE FOR DISLOCATION. EVENT HAPPENED IN AUSTRALIA.
BY CHECKING THE DHR OF THE INVOLVED LOT#S NO PRE - EXISTING ANOMALIES WERE FOUND. THIS IS THE FIRST AND ONLY COMPLAINT INVOLVING THESE LOT #S. WE WILL SUBMIT A FINAL REPORT ONCE THE INVESTIGATION WILL BE CONCLUDED.
REVISION SURGERY DUE TO SHOULDER DISLOCATION OCCURRED ON (B)(6) 2019. PREVIOUS SURGERY OCCURRED ON (B)(6) 2019 WAS ALSO A REVISION (MFR 3008021110-2019-00035) AND WAS DUE TO LOOSENING OF THE METAL BACK. DURING THE FIRST REVISION, SURGEON DECIDED TO IMPLANT THE GLENOID HIGH TO IMPROVE THE STABILITY OF THE IMPLANT BECAUSE OF THE BETTER BONE QUALITY. HOWEVER, THE IMPLANT DISLOCATED AND SURGEON DECIDED TO EXCHANGE FOR LATERALIZED LINER WITH NEW STEM AND BODY. DURING THE CURRENT SURGERY THE FOLLOWING COMPONENTS WERE EXPLANTED: LATERALIZED MEDIUM LINER 44MM, COD #1362.09.115, LOT #1804713. REVERSE HUMERAL BODY SHORT, COD #1352.15.005, LOT #1816260. FINNED STEM 12MM, COD #1304.15.120, LOT #1500641. EVENT OCCURRED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282018 | SMR REVERSE HUMERAL BODY SHORT | SMR REVERSE HUMERAL BODY SHORT | KWS | LIMACORPORATE SPA | 1352.15.005 | 1817981 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |