145-DEG PE 36MM HUM LINER +0
Report
- Report Number
- 1038671-2024-04736
- Event Type
- Injury
- Date Received
- December 10, 2024
- Date of Event
- November 18, 2024
- Report Date
- September 29, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- KWS
- UDI-DI
- 10885862086617
- PMA / PMN Number
- K093275
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
D11 CONCOMITANT DEVICES: A10012 - GPS IMPLANT KIT V2 09003122202, 320-35-02 - SMALL SUPERIOR AUGMENT GLENOID PLATE A006673, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM A155072, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM A166808, 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM A193925, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT A266892, 531-55-88 - ERGO GPS 3.2MM DRILL KIT STERILE A339914, 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM A343046, 531-78-20 - SHOULDR GPS HEX PINS KIT A365632, 320-15-05 - EQ REV LOCKING SCREW A369536, 320-31-36 - GLENOSPHERE, 36MM A373322, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 A405792, 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM S382797.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E. THE REASON FOR THE REVISION REPORTED WAS LIKELY THE RESULT OF INFECTION AS REPORTED. THE CAUSE OF THE REPORTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO THE PATIENT¿S PREVIOUS COLOSTOMY PROCEDURE AND/OR UNDERLYING PATIENT CONDITION. THE PROSTHESIS WEAR NOTED ON THE EXPLANTED HUMERAL LINER IS LIKELY THE RESULT OF IMPINGEMENT BETWEEN THE HUMERAL LINER AND NATIVE GLENOID BONE. HOWEVER, THIS CANNOT BE CONFIRMED AS DEVICES WERE NOT RETURNED FOR EVALUATION AND NO RADIOGRAPHS WERE PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
EXPERIENCE REPORT USA. IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED. SINCE THE INDEX SURGERY, THE PATIENT HAD A COLOSTOMY PLACED. AT SOME POINT AFTER, PATIENT DEVELOPED AN INFECTION. IT IS UNCLEAR IF HER INFECTION IS RELATED TO THE COLOSTOMY PROCEDURE. PATIENT HAD AN ABSCESS WITHIN THE SOFT TISSUE OF HER DELTOID. SURGEON DRAINED THE ABSCESS AND PERFORMED A ONE-STAGE REVISION. HE EXPLANTED ALL THE ORIGINAL HARDWARE AND IMPLANTED A NEW SMALL SUPERIOR AUGMENT BASEPLATE, BLUE, RED, AND BLACK SCREWS AND CAPS, 40 EXPANDED SPHERE, LOCKING SCREW, CEMENTED 12MM STEM, 0 TRAY, REVERSE TORQUE SCREW AND A 2.5MM LINER. ORIGINAL LINER HAD SOME WEAR ALREADY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IS THE REPORTED EVENT ASSOCIATED WITH REVISION OF EXACTECH IMPLANTS? YES. WHAT SIDE WAS EFFECTED? RIGHT. DO YOU KNOW THE INITIAL IMPLANT DATE (INDEX SURGERY DATE)? KNOWN. PROVIDE THE INITIAL IMPLANT DATE (INDEX SURGERY DATE) (B)(6)2023. WAS THE PATIENT REVISED TO EXACTECH DEVICES? YES. PLEASE DESCRIBE BELOW: DR. (B)(6) PERFORMED A ONE-STAGE REVISION. HE EXPLANTED ALL THE ORIGINAL HARDWARE AND IMPLANTED A NEW SMALL SUPERIOR AUGMENT BASEPLATE, BLUE, RED, AND BLACK SCREWS AND CAPS, 40 EXPANDED SPHERES, LOCKING SCREW, CEMENTED 12MM STEM, 0 TRAY, REVERSE TORQUE SCREW AND A 2.5MM LINER. ORIGINAL LINER HAD SOME WEAR ALREADY. IS THE REPORTED EVENT RELATED TO THE BREAKAGE OF A DEVICE? NO. DID THE REPORTED EVENT LEAD TO A SURGICAL DELAY/PROLONGATION? YES. HOW LONG WAS THE DURATION (IN MINUTES): > 45 MINS DID THE PATIENT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE SURGICAL DELAY/PROLONGATION? NO. PLEASE DESCRIBE BELOW: DELAY IN THE SENSE OF THE NEED FOR REVISION SURGERY AT ALL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND EBI ATTACHED. X-RAYS UNAVAILABLE. PRODUCTS NOT RETURNING: HOSPITAL KEEPS. 320-36-00 36MM HUMERAL LINER +0 UNCONSTRAINED (B)(6). UDI NUMBER (B)(4). 510(K) NUMBER K093275. PRODUCT CODE KWS, KWT. CONCOMITANTS: (B)(6) - GPS IMPLANT KIT V2 (B)(6). 320-35-02 - SMALL SUPERIOR AUGMENT GLENOID PLATE (B)(6). 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM (B)(6). 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM (B)(6). 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM (B)(6). 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT (B)(6). 531-55-88 - ERGO GPS 3.2MM DRILL KIT STERILE (B)(6). 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM (B)(6). 531-78-20 - SHOULDR GPS HEX PINS KIT (B)(6). 320-15-05 - EQ REV LOCKING SCREW (B)(6). 320-31-36 - GLENOSPHERE, 36MM (B)(6). 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 (B)(6). 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM (B)(6).
IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED. SINCE THE INDEX SURGERY, THE PATIENT HAD A COLOSTOMY PLACED. AT SOME POINT AFTER, PATIENT DEVELOPED AN INFECTION. IT IS UNCLEAR IF HER INFECTION IS RELATED TO THE COLOSTOMY PROCEDURE. PATIENT HAD AN ABSCESS WITHIN THE SOFT TISSUE OF HER DELTOID. SURGEON DRAINED THE ABSCESS AND PERFORMED A ONE-STAGE REVISION. HE EXPLANTED ALL THE ORIGINAL HARDWARE AND IMPLANTED A NEW SMALL SUPERIOR AUGMENT BASEPLATE, BLUE, RED, AND BLACK SCREWS AND CAPS, 40 EXPANDED SPHERE, LOCKING SCREW, CEMENTED 12MM STEM, 0 TRAY, REVERSE TORQUE SCREW AND A 2.5MM LINER. ORIGINAL LINER HAD SOME WEAR ALREADY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1696467 | 145-DEG PE 36MM HUM LINER +0 | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | KWS | EXACTECH, INC. | 10885862086617 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | Required Intervention |