GMRS EXTENSION PC 40MM LF
Report
- Report Number
- 0002249697-2024-00291
- Event Type
- Injury
- Date Received
- February 26, 2024
- Date of Event
- January 31, 2024
- Report Date
- April 4, 2024
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- KRO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AN EVENT REGARDING OTHER (DEVICE DOES NOT MATCH THE DESIGN PLAN) INVOLVING A CUSTOM GMRS EXTENSION PIECE WAS REPORTED. THE EVENT WAS CONFIRMED VIA EVALUATION OF THE RETURNED DEVICE. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE BY THE GQO TEAM INDICATED THAT THE PART ORIENTATION WAS INCORRECT. THE ANGLE BETWEEN THE FLATS AND THE TABS INDICATED THAT THE IMPLANT WAS ORIENTED TO A RIGHT SIDE VS. THE INTENDED LEFT SIDE. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT THE DEVICE DID NOT MATCH THE DESIGN PROPOSAL AND APPEARED TO BE ROTATED 180 DEGREES FROM THE PLAN. THE ISSUE WAS NOT NOTICED UNTIL THE REVISION PROCEDURE WAS UNDERWAY AND ALL COMPONENTS HAD BEEN EXPLANTED. THE ORIGINAL COMPONENTS WERE RE-IMPLANTED IN THE PATIENT AND THE PROCEDURE WAS ABORTED. VISUAL INSPECTION OF THE RETURNED DEVICE BY THE GQO TEAM INDICATED THAT THE PART ORIENTATION WAS INCORRECT. THE ANGLE BETWEEN THE FLATS AND THE TABS INDICATED THAT THE IMPLANT WAS ORIENTED TO A RIGHT SIDE VS. THE INTENDED LEFT SIDE. A NC HAS BEEN RAISED TO ADDRESS THIS ISSUE.
AN INVESTIGATION SHALL BE PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
CUSTOM IMPLANT SUPPLIED FOR REVISION PROCEDURE DID NOT MATCH DESIGN PROPOSAL. THE REP REPORTS REVIEWING AND APPROVING THE PLAN FOR THIS CUSTOM IMPLANT. IN HIS OPINION WHEN THEY OPENED THE IMPLANT TODAY IT IS 180 ROTATED COMPARED TO THE PLAN. THE REP REPORTS THE SURGEON TRYING TO SEE IF THERE WAS ANY WAY THEY COULD MAKE IMPLANT FIT WITHOUT IT BEING 180 ROTATED. HE REPORTS THAT THIS WAS NOT SUCCESSFUL AND THAT THE SURGEON DECIDED TO ABORT THE OPERATION. ADDITIONAL INFORMATION RECEIVED: THE PATIENT WAS UNDER ANESTHESIA & EXISTING COMPONENTS REMOVED BEFORE THE ISSUE WITH THE CUSTOM IMPLANT WAS IDENTIFIED. THE SURGEON RE-IMPLANTED THE ORIGINAL COMPONENTS. WE ARE STILL WAITING FOR CONFIRMATION ON HOW THE PATIENT WOULD LIKE TO PROCEED.
CUSTOM IMPLANT SUPPLIED FOR REVISION PROCEDURE DID NOT MATCH DESIGN PROPOSAL. THE REP REPORTS REVIEWING AND APPROVING THE PLAN FOR THIS CUSTOM IMPLANT. IN HIS OPINION WHEN THEY OPENED THE IMPLANT TODAY IT IS 180 ROTATED COMPARED TO THE PLAN. THE REP REPORTS THE SURGEON TRYING TO SEE IF THERE WAS ANY WAY THEY COULD MAKE IMPLANT FIT WITHOUT IT BEING 180 ROTATED. HE REPORTS THAT THIS WAS NOT SUCCESSFUL AND THAT THE SURGEON DECIDED TO ABORT THE OPERATION. ADDITIONAL INFORMATION RECEIVED: THE PATIENT WAS UNDER ANESTHESIA & EXISTING COMPONENTS REMOVED BEFORE THE ISSUE WITH THE CUSTOM IMPLANT WAS IDENTIFIED. THE SURGEON RE-IMPLANTED THE ORIGINAL COMPONENTS. WE ARE STILL WAITING FOR CONFIRMATION ON HOW THE PATIENT WOULD LIKE TO PROCEED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297397 | GMRS EXTENSION PC 40MM LF | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER | KRO | STRYKER ORTHOPAEDICS-MAHWAH | HX2H9A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female | Hospitalization| R |