MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-600
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding malposition involving a triathlon baseplate was reported.The event 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: -clinician review: no medical records were received for review with a clinical consultant.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 that upon closing of the incision it was discovered that the tibial implant had been implanted in internal rotation thus making the joint unstable.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 revision 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.H3 other text : not returned.
Event or Problem Description
This pi is for the same-day revision on (b)(6) 2023.As reported: please find attached information from a revision of left total knee done (b)(6) 2023.There is attached information from the index surgery and a previous revision.The previous revision was removal of the knee implants due to infection and placement of a temporary implant to treat the infection.On (b)(6) the temporary implants were removed and final implants were placed (first usage sheet for (b)(6) 2023).Upon closing of the incision it was discovered that the tibial implant had been implanted in internal rotation thus making the joint unstable.The incision was opened back up and the tibia was revised.The second sheet has the final tibial implants and the implants that were removed are circled on the first sheet.Stryker instruments (including mako from index surgery) were not thought to have contributed to any of the complications.

• Brand Name: TRI TS BASEPLATE SIZE 6
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18279100
• Report Number: 0002249697-2023-01498
• Device Sequence Number: 12436490
• Product Code: MBH
• UDI-Device Identifier: 07613327026337
• UDI-Public: 07613327026337
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2023

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 Catalogue Number: 5521-B-600
• Device Lot Number: OLS9XA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2023
• 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: 55 YR
• Patient Sex: Male