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

Model Number	5521-B-600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377)
Date of Event	10/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
It was reported that the patient's left knee was revised due to tibial pain.Intra-operatively, the following were observed: osteolysis and fracture of the medial tibia, and the insert appeared to have been pitted.The baseplate and insert were revised.
Event or Problem Description
It was reported that the patient's left knee was revised due to tibial pain.Intra-operatively, the following were observed: osteolysis and fracture of the medial tibia, and the insert appeared to have been pitted.The baseplate and insert were revised.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture and osteolysis involving a triathlon baseplate was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device has bone cement residue on the distal side.Minor scratches are also visible on the surfaces of the device.Damage is consistent with attempted implantation/explantation.No wear is visible on the device.-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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12859113
• Report Number: 0002249697-2021-01944
• Device Sequence Number: 4609130
• Product Code: MBH
• UDI-Device Identifier: 07613327026337
• UDI-Public: 07613327026337
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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 Expiration Date: 11/28/2023
• Device Model Number: 5521-B-600
• Device Catalogue Number: 5521-B-600
• Device Lot Number: DIE3YA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 101 KG