MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5521-B-500
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event an event regarding malposition involving a triathlon baseplate was reported.The event was confirmed via clinician review.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: confirmation: the event was confirmed a valgus knee underwent surgery, the resultant construct was malposition.Root cause: the root cause cannot be determined without additional medical information.Product history review: review of the device history records indicate 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 after a mako tka surgery, the surgeon was not happy with outcome of surgery.Patient started in valgus and ended up in varus.Clinician review of provided medical records indicated that the event was confirmed; a valgus knee underwent surgery, the resultant construct was malposition.The exact cause of the event could not be determined because insufficient information was provided.Further information such as mako segmentation files are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Surgeon not happy with outcome of surgery.Pt started in valgus ended up in varus.

• Brand Name: TRI TS BASEPLATE SIZE 5
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12665052
• Report Number: 0002249697-2021-01728
• Device Sequence Number: 19134538
• Product Code: MBH
• UDI-Device Identifier: 07613327026320
• UDI-Public: 07613327026320
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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: 09/30/2025
• Device Model Number: 5521-B-500
• Device Catalogue Number: 5521-B-500
• Device Lot Number: GIZ3RA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR