MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SOLID CS TIBIAL INSERT TRIAL SIZE 2 - 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-T-209Y
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection: visual inspection of the returned device indicated that a posterior portion of the device had fractured off.The fractured piece was also returned.Material analysis: "review of triathlon solid cs tibial insert trial size 2, catalogue # 5531-t-209y, lot code a2268 confirmed fracture on the posterior articulating surface edge.Characterization using stereo microscopy confirmed fracture on the posterior articulating surface edge due to overload fracture.No manufacturing or material related defects were observed on the fracture surfaces examined." clinician review: no medical records were received for review with a clinical consultant.Device history review: a review of the device history records indicates 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.Conclusion: it was reported that the trial appears to have been damaged by fatigue."review of triathlon solid cs tibial insert trial size 2, catalogue # 5531-t-209y, lot code a2268 confirmed fracture on the posterior articulating surface edge.Characterization using stereo microscopy confirmed fracture on the posterior articulating surface edge due to overload fracture.No manufacturing or material related defects were observed on the fracture surfaces examined." no further investigation for this event is required.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Trial appears to have been damaged by fatigue.Update: revision to remove fragment from patient.

• Brand Name: TRIATHLON SOLID CS TIBIAL INSERT TRIAL SIZE 2 - 9MM
• 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: 15683771
• Report Number: 0002249697-2022-01557
• Device Sequence Number: 6462805
• Product Code: MBH
• UDI-Device Identifier: 07613327404487
• UDI-Public: 07613327404487
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2022

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 Model Number: 5531-T-209Y
• Device Catalogue Number: 5531-T-209Y
• Device Lot Number: A2268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75
• Patient Sex: Unknown
• Patient Weight: 70