MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON ASYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5551-G-381-E
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection and crack/fracture involving a triathlon patella 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: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 04/28/2022 with no relevant reported discrepancies.Complaint history review: there has been 1 other similar event for the lot referenced.There has been 1 other similar events for the reported sterile lot.Said event relates to infection for the same device/patient, therefore no further trending is required for this commonality.No similar event for crack/fracture.Conclusions: all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.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.The following devices were also listed in this report: x3 triathlon cs insert #7 11mm; cat# 5531-g-711-e; lot# ea7vt5; triathlon cr fem comp #6 l-cem; cat# 5510f601; lot# nax7r; tri ts baseplate size 7; cat# 5521-b-700; lot# g4l7ha; simplex hv us 1 pack; cat# 6194-1-001; lot# 112aa907kb (qty 2); it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : not returned.
Event or Problem Description
It was reported that the patient's left knee was revised due to infection and patella fracture.All implants (including the patella) were removed, and a femoral component with an all poly tibia were implanted.

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• 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: 16951776
• Report Number: 0002249697-2023-00551
• Device Sequence Number: 6915906
• Product Code: MBH
• UDI-Device Identifier: 07613327314700
• UDI-Public: 07613327314700
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2023

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 Model Number: 5551-G-381-E
• Device Catalogue Number: 5551-G-381-E
• Device Lot Number: 4YE9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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: 71 YR
• Patient Sex: Male