MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CS #7 10MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-710-E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right knee was revised due to stiffness.It was discovered that the locking wire was disengaged from the baseplate.Surgeon reported he suspects the insert was never locked in properly.A 7x10 cs insert was revised to a 7x9 cs insert.Rep reported that he can provide pictures and possibly obtain the explanted insert for return.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and rom involving a triathlon insert was reported.The event of disassociation was confirmed via clinician review; the event of rom was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: undated/unlabeled: ap/lateral knee x-rays.Uncemented triathlon with tritanium baseplate.The locking wire does not appear engaged on either view and looks bent.Confirmation: a revision cannot be confirmed without additional records.The mis-locking of the wire/bending of the wire can be confirmed on the x-rays.Root cause: additional records would be required to determine a root cause, but the likely cause would be insertional error/difficulty that lead to dislodging part of the wire.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient's right knee was revised due to stiffness.It was discovered that the locking wire was disengaged from the baseplate.Clinician review of provided x-rays confirmed the mis-locking of the wire/bending of the wire.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.
Event or Problem Description
It was reported that the patient's right knee was revised due to stiffness.It was discovered that the locking wire was disengaged from the baseplate.Surgeon reported he suspects the insert was never locked in properly.A 7x10 cs insert was revised to a 7x9 cs insert.Rep reported that he can provide pictures and possibly obtain the explanted insert for return.

• Brand Name: X3 TRIATHLON INSERT CS #7 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12813451
• Report Number: 0002249697-2021-01891
• Device Sequence Number: 20211543
• Product Code: MBH
• UDI-Device Identifier: 07613327392234
• UDI-Public: 07613327392234
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2022

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 Model Number: 5531-G-710-E
• Device Catalogue Number: 5531-G-710-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male