AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA
Report
- Report Number
- 3000931034-2024-00140
- Event Type
- Injury
- Date Received
- March 25, 2024
- Date of Event
- September 1, 2023
- Report Date
- June 20, 2024
- Manufacturer
- TORNIER S.A.S.
- Product Code
- KWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE (DWD002) IS COMMERCIALLY AVAILABLE AND CLEARED UNDER 510K # K050316. BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE DISPOSITION UNKNOWN.
THE REPORTED EVENT WAS NOT CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED FOR INVESTIGATION (REMAINED IMPLANTED). THE OPINION OF THE MEDICAL EXPERT WAS REQUESTED ON THIS CASE DESPITE THE LIMITED INFORMATION PROVIDED, AND STATED AS FOLLOWING: "THE HIGH AGE OF THE PATIENT AND A TRAUMA ARE SUFFICIENT TO FRACTURE AN ACROMION. THE FACT THAT IT HEALED WITHOUT INTERVENTION SHOWS THERE IS NOT AN ABNORMAL STRESS ON THE ACROMION. THE RADIOGRAPHIC FINDING OF NOTCHING, INVOLVING THE INFERIOR PERIPHERAL SCREW MAY BE CAUSED BY SEVERAL FACTORS (GLENOID PLACEMENT, NSA ANGLE OF THE HUMERAL COMPONENT, AND INDIVIDUAL SHOULDER USE BY THE PATIENT). WITHOUT ANY FURTHER INFORMATION, THIS RADIOGRAPHIC FINDING CANNOT BE ASSESSED". 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 LOT NUMBER WAS NOT COMMUNICATED. 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. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.
IN THE TORNIER SHOULDER OUTCOMES STUDY, A TRAUMATIC ACROMIAL FRACTURE OCCURRED POSTOPERATIVELY. THE ADVERSE EVENT RESOLVED WITHOUT SEQUELAE. IT WAS ASSESSED AS NOT RELATED TO THE STUDY DEVICE OR THE SURGICAL PROCEDURE. AN UPDATE NOTED THAT NO ACTION WAS TAKEN, AND NO TREATMENT WAS ADMINISTERED. DURING THE VISIT, GLENOID NOTCHING WAS OBSERVED, WITH THE NOTCH EXTENDING TO THE LOWER SCREW AND GLENOID LUCENCIES INVOLVING THE BASEPLATE (SUPERIOR OR INFERIOR).
IN THE TORNIER SHOULDER OUTCOMES STUDY, A TRAUMATIC ACROMIAL FRACTURE OCCURRED POSTOPERATIVELY. THE ADVERSE EVENT RESOLVED WITHOUT SEQUELAE. IT WAS ASSESSED AS NOT RELATED TO THE STUDY DEVICE OR THE SURGICAL PROCEDURE. AN UPDATE NOTED THAT NO ACTION WAS TAKEN, AND NO TREATMENT WAS ADMINISTERED. DURING THE VISIT, GLENOID NOTCHING WAS OBSERVED, WITH THE NOTCH EXTENDING TO THE LOWER SCREW AND GLENOID LUCENCIES INVOLVING THE BASEPLATE (SUPERIOR OR INFERIOR).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10737 | AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | KWS | TORNIER S.A.S. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | Required Intervention |