UNKNOWN PERFORM REVERSED ECCENTRIC GLENOSPHERES
Report
- Report Number
- 3000931034-2022-00300
- Event Type
- Malfunction
- Date Received
- September 12, 2022
- Date of Event
- August 17, 2022
- Report Date
- January 18, 2023
- Manufacturer
- TORNIER S.A.S.
- Product Code
- KWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE CATALOG NUMBER AND LOT NUMBER WERE NOT COMMUNICATED. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.
PLEASE NOTE CORRECTIONS IN: B1: ADVERSE EVENT/PRODUCT PROBLEM. B5: IN THE EXECUTIVE SUMMARY: THIS IS CASE # 7 OUT OF 7. D2A: COMMON DEVICE NAME: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED. D2B: PRODUCT CODE KWS. H1: TYPE OF REPORTABLE EVENT: SERIOUS INJURY.
PLEASE NOTE CORRECTIONS TO THE FDA REGISTRATION NUMBER, MDR WAS SUBMITTED UNDER 3000931034 BUT SHOULD HAVE BEEN SUBMITTED UNDER 1649390 D3, G1 MFG SITE, THE H6 DEVICE CODE, RESULTS CODE, AND CONCLUSIONS CODE: THE REPORTED EVENT COULD BE CONFIRMED. A REVIEW BY R&D DETERMINED THAT THERE WAS EVIDENCE OF A DISLOCATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. SINCE DATA WAS PROVIDED, THE OPINION OF R&D WAS SOUGHT AND STATED AS FOLLOWS: «ONE OF THE DESIGN SURGEONS (A PERFORM HUMERAL DESIGNER) VISITED TEXAS TO MEET WITH THE REPORTING SURGEON THIS CASE ON THIS TOPIC. THE DESIGN SURGEON REVIEWED THE 7 CASES THAT HAD DISLOCATIONS AND 60-70 OTHERS THAT DID NOT TO LOOK FOR A COMMON THREAD THAT MIGHT LEAD TO THESE DISLOCATIONS. THE DESIGN SURGEON ALSO SPENT TIME IN THE OR OBSERVING THE REPORTING SURGEON¿S SURGICAL TECHNIQUE. THE FOLLOWING ARE OBSERVATIONS NOTED BY THE DESIGN SURGEON: - THEY BOTH NOTED THAT THIS HAPPENED ON PATENTS WITH CUFF TEAR ARTHROPATHY WHO WERE HIGHLY MOBILE PRIOR TO SURGERY. ALL 7 PATIENTS HAD VERY QUICK RETURNS TO NORMAL, SUCH THAT IT WAS UNLIKELY FOR SOME OF THE SOFT TISSUES TO FULLY HEAL PRIOR TO NORMAL ACTIVITY. O TWO OF THEM WERE ASSOCIATED WITH SPECIFIC EVENTS: 1 A FALL AND 1 LIFTING A GRANDCHILD SEVERAL WEEKS AFTER SURGERY. - THE DESIGN SURGEON REPORTED THAT THE REPORTING SURGEON HAS NOT CHANGED THE TECHNIQUE WHEN SWITCHING FROM FLEX TO PERFORM. THE REPORTING SURGEON TENDS TO TAKE AN AGGRESSIVE HEAD CUT DESPITE RECOMMENDATIONS TO BE LESS AGGRESSIVE. O SOME TYPE OF ADAPTATION HERE IS NECESSARY TO ACCOUNT FOR THE INLAY NATURE OF THE PROTHESIS. - THIS RESULTS IN THE STEM GENERALLY BEING TOO LOW AND TRYING TO ACHIEVE DISTAL PRESSFIT RATHER THAN THE INTENDED METAPHYSEAL PRESSFIT. - THE DESIGN SURGEON REPORTED THAT THE REPORTING SURGEON LETS HIS RESIDENT REPAIR THE SUBSCAP WITHOUT ANY TRANSOSSEOUS REPAIRS, ONLY TENDON TO TENDON REPAIRS ALSO REHAB ONLY INCLUDED A SLING AT NIGHT TIME¿NOTHING DURING THE DAY TO PROTECT THIS SUBSCAP REPAIR.¿ BASED ON INVESTIGATION, THE ROOT CAUSE IS FAILURE TO FOLLOW INSTRUCTIONS AS THERE IS AN EVIDENT DEVIATION FROM THE SURGICAL TECHNIQUE. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.
IT WAS REPORTED THAT DURING A PHONE CALL WITH A PHYSICIAN, THE PHYSICIAN NOTED THAT THERE WERE 7 CASES OF INSTABILITY IN APPROXIMATELY 130 CASES THAT THEY WERE INVOLVED WITH. THE PHYSICIAN FOUND THESE CASES TO BE DISLOCATIONS OCCURRING DURING THE FORWARD ELEVATION AND OFTEN DISLOCATION IN THE ANTERIOR SUPERIOR DIRECTION. THE PHYSICIAN USES PERFORM REVERSE FULL WEDGE BASEPLATES ON ALMOST ALL PATIENTS WITH 39 ECCENTRIC SPHERES ON WOMEN AND 42 MM ECCENTRIC ON MEN. THE PHYSICIAN FINDS THAT THEY ARE MOSTLY PUTTING IN +3 POLY THICKNESS TO GET THE DESIRED TENSION. THE HUMERAL HEAD IS CUT MADE AT THE ANATOMICAL NECK.
IT WAS REPORTED THAT DURING A PHONE CALL WITH A PHYSICIAN, THE PHYSICIAN NOTED THAT THERE WERE 7 CASES OF INSTABILITY IN APPROXIMATELY 130 CASES THAT THEY WERE INVOLVED WITH. THE PHYSICIAN FOUND THESE CASES TO BE DISLOCATIONS OCCURRING DURING THE FORWARD ELEVATION AND OFTEN DISLOCATION IN THE ANTERIOR SUPERIOR DIRECTION. THE PHYSICIAN USES PERFORM REVERSE FULL WEDGE BASEPLATES ON ALMOST ALL PATIENTS WITH 39 ECCENTRIC SPHERES ON WOMEN AND 42 MM ECCENTRIC ON MEN. THE PHYSICIAN FINDS THAT THEY ARE MOSTLY PUTTING IN +3 POLY THICKNESS TO GET THE DESIRED TENSION. THE HUMERAL HEAD IS CUT MADE AT THE ANATOMICAL NECK. CASE 7 OUT OF 7.
IT WAS REPORTED THAT DURING A PHONE CALL WITH A PHYSICIAN, THE PHYSICIAN NOTED THAT THERE WERE 7 CASES OF INSTABILITY IN APPROXIMATELY 130 CASES THAT THEY WERE INVOLVED WITH. THE PHYSICIAN FOUND THESE CASES TO BE DISLOCATIONS OCCURRING DURING THE FORWARD ELEVATION AND OFTEN DISLOCATION IN THE ANTERIOR SUPERIOR DIRECTION. THE PHYSICIAN USES PERFORM REVERSE FULL WEDGE BASEPLATES ON ALMOST ALL PATIENTS WITH 39 ECCENTRIC SPHERES ON WOMEN AND 42 MM ECCENTRIC ON MEN. THE PHYSICIAN FINDS THAT THEY ARE MOSTLY PUTTING IN +3 POLY THICKNESS TO GET THE DESIRED TENSION. THE HUMERAL HEAD IS CUT MADE AT THE ANATOMICAL NECK. CASE 7 OUT OF 7.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2392353 | UNKNOWN PERFORM REVERSED ECCENTRIC GLENOSPHERES | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | KWS | TORNIER S.A.S. | UNKNOWN | ||
| 2788303 | UNKNOWN PERFORM REVERSED ECCENTRIC GLENOSPHERES | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | KWS | TORNIER S.A.S. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization| R |