EQUINOXE REVERSE SHOULDER COMPONENTS
Report
- Report Number
- 1038671-2022-01321
- Event Type
- Injury
- Date Received
- October 18, 2022
- Date of Event
- September 20, 2022
- Report Date
- January 20, 2026
- Manufacturer
- EXACTECH, INC.
- Product Code
- KWT
- UDI-DI
- 10885862086655
- PMA / PMN Number
- K063569
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
NO DEVICE RETURN ANTICIPATED AS THE HOSPITAL DISCARDED THEM. CONCOMITANT MEDICAL PRODUCTS: 2004322319 A10012 - GPS IMPLANT KIT V2, 6124050 308-05-22 - DISTAL FIXATION RING HA 22.5, 6472353 308-10-50 - 50MM MIDDLE SEGMENT MODULAR, 6699356 308-09-00 - SMALL PROX BODY +0, 6997778 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE, 7022568 308-15-50 - TAPER LOCKING SCREW 50, 7026732 308-02-09 - 9X120MM DISTAL STEM MODULAR CEMENTED, A007912 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM, A112789 320-15-05 - EQ REV LOCKING SCREW, A116220 531-78-20 - SHOULDR GPS HEX PINS KIT, A119490 320-15-01 - EQ REV GLENOID PLATE, A125134 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT, A127564 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, S359954 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM, S365063 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM, S375498 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM, S375500 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE DISLOCATION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, D4 (REMOVE ALL FROM INITIAL REPORT-SUSPECT DEVICE UNKNOWN), G4 (REMOVE 501K FROM INITIAL REPORT-UNKNOWN), H4 (REMOVE ERRONEOUS DATE FROM INITIAL REPORT-UNKNOWN), H6 MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE, FINDINGS AND CONCLUSION INVESTIGATION CODE. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H3, H6, H11. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION REPORTED IN CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION IS A KNOWN RISK, AS OUTLINED IN THE IFU. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.
IT WAS REPORTED THAT A MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2022, DISLOCATED POST-SURGERY AND WAS REVISED ON (B)(6) 2022. THE ZERO LINER WAS REPLACED WITH A 38MM CONSTRAINED LINER. NEW GLENOSPHERE SCREW WAS USED AS GLENOSPHERE WAS REMOVED FOR ACCESS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICES ARE RETURNING AS THE HOSPITAL DISCARDED THEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291996 | EQUINOXE REVERSE SHOULDER COMPONENTS | PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER | KWT | EXACTECH, INC. | EQUINOXE REVERSE 38MM HUMERAL LINER +0 | UNK | 10885862086655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization| R | SEE H10. |