MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL COMP KIN HINGE KNEE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, TRUNNION-BEARING

Catalog Number	64753933
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
This pi is for revision of the patient's left knee.As reported: left knee revision.Rotating component broken & explanted.New components attempted to be implanted however diameters were too large so would fit.Hospital disposed of explants so not available for return.Caused delay of 10 minutes attempting to make new implants fit into patient.No specific trauma caused to patient.Additional information regarding wasted implants: all 3 bushings wasted/not implanted because they too big of a diameter to fit in femoral component already in patient.We did not have the correct bushings due to lack of implant details specific to patient prior to the surgery.The representative was misinformed by the surgeon.So the surgeon attempted to implant the wrong bushings were inadvertently & found out intra-operatively they were incorrect.The surgeon elected to implant rotating component axle, & new bumper.They were able to fit without using bushings.
Event or Problem Description
This pi is for revision of the patient's left knee.As reported: left knee revision.Rotating component broken & explanted.New components attempted to be implanted however diameters were too large so would fit.Hospital disposed of explants so not available for return.Caused delay of 10 minutes attempting to make new implants fit into patient.No specific trauma caused to patient.Additional information regarding wasted implants: all 3 bushings wasted/not implanted because they too big of a diameter to fit in femoral component already in patient.We did not have the correct bushings due to lack of implant details specific to patient prior to the surgery.The representative was misinformed by the surgeon.So the surgeon attempted to implant the wrong bushings were inadvertently & found out intra-operatively they were incorrect.The surgeon elected to implant rotating component axle, & new bumper.They were able to fit without using bushings.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an mrh tibial component was reported.The event was confirmed via evaluation of the provided photographs.Method & results: -product evaluation and results: visual inspection: the device was not returned; however, photographs were provided for evaluation.The photographs show a recently explanted tibial baseplate.The device seems to be broken.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate that devices were 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 patient was revised due to tibial component fracture.The device was not returned; however, photographs were provided for evaluation.The photographs show a recently explanted tibial component.The device seems to have been broken.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TIBIAL COMP KIN HINGE KNEE
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, TRUNNION-BEARING
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18279652
• Report Number: 0002249697-2023-01501
• Device Sequence Number: 6043554
• Product Code: LGE
• UDI-Device Identifier: 07613327046656
• UDI-Public: 07613327046656
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K811630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2004
• Device Catalogue Number: 64753933
• Device Lot Number: FXOLD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/1999
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female