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

Model Number	5532-G-516
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.The following devices were also listed in this report: triathlon ps fem component, cemented; cat # 5515-f-502; lot # u4bla.Tri ts baseplate size 5; cat # 5521-b-500; lot # wosga.Triathlon symmetric x3 patella; cat # 5550-g-360; lot # 3eyp.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Surgical site infection, right knee.
Event or Problem Description
Surgical site infection, right knee.
Additional Manufacturer Narrative
An event regarding infection involving a triathlon insert 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: adverse event identified patella implant fracture (shear of the pegs) requiring revision surgery and subsequent postoperative surgical site infection requiring revision surgery.Hazards: there was a potential hazard.The patellar component, by report, fractured-sheared off at the peg level and was loose.This required revision surgery and led to an infection.Conclusion of assessment: there was a patella implant fracture (shear of the pegs) that required revision surgery.A postoperative surgical site infection occurred and required another revision surgery.While there was some evidence of trauma, this would be an unusual failure mechanism especially with a cemented patella.Evaluation of the explant, assessment of radiographs, and operative notes from the patellar revision as well as an extended patient history may provide an ability to assess the root cause of the event.-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.There have been no other similar events for the sterile lot referenced.Conclusions: all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, 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 become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: triathlon ps fem component, cemented; cat # 5515-f-502; lot # u4bla.Tri ts baseplate size 5; cat # 5521-b-500; lot # wosga.Triathlon symmetric x3 patella; cat # 5550-g-360; lot # 3eyp.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: 12189432
• Report Number: 0002249697-2021-01223
• Device Sequence Number: 3590918
• Product Code: MBH
• UDI-Device Identifier: 07613327050806
• UDI-Public: 07613327050806
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 12/31/2020
• Device Model Number: 5532-G-516
• Device Catalogue Number: 5532-G-516
• Device Lot Number: A264X2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 11/03/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 100