MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SOLID CR TIBIAL INSERT TRIAL SIZE 6 - 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	5530-T-609Y
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, right knee.It was reported that during trailing, the posterior aspect of the 6x9 cr trial broke in the patient.All pieces were removed, patient was visually inspected, and device was reassembled at the back table to ensure nothing remained in the patient.Case was completed successfully with a surgical delay of approximately 1 minute.The device is available for return.Otherwise, the rep confirmed that no further information will available.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed by product inspection.Method & results: product evaluation and results: visual inspection of the the returned device identified a fracture posterior to the articulating surface.The device also showed signs of wear and tear typical for similar reusable instruments.These findings were confirmed in the material analysis report.Clinician review: not performed as there was no medical records provided.Product history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: here have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.The conditions under which the fracture occurred, including when during the workflow the fracture occurred or if this device was being used in conjunction with other devices, are not known.Additional information including operative reports are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Primary procedure, right knee.It was reported that during trialling, the posterior aspect of the 6x9 cr trial broke in the patient.All pieces were removed, patient was visually inspected, and device was reassembled at the back table to ensure nothing remained in the patient.Case was completed successfully with a surgical delay of approximately 1 minute.The device is available for return.Otherwise, the rep confirmed that no further information will available.

• Brand Name: TRIATHLON SOLID CR TIBIAL INSERT TRIAL SIZE 6 - 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9155859
• Report Number: 0002249697-2019-03382
• Device Sequence Number: 1848719
• Product Code: JWH
• UDI-Device Identifier: 07613327402803
• UDI-Public: 07613327402803
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5530-T-609Y
• Device Catalogue Number: 5530-T-609Y
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 03/10/2020
• 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: Other
• Patient Age: 61 YR