MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR BASEPLATE #4 RM/LL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	5620-B-402
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	04/10/2020
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.
Event or Problem Description
After the operation, it was confirmed that the inner condyle of the tibia was fractured.Osteosynthesis is scheduled for (b)(6).
Event or Problem Description
After the operation, it was confirmed that the inner condyle of the tibia was fractured.Osteosynthesis is scheduled for (b)(6) 2017.
Additional Manufacturer Narrative
Reported event: an event regarding intraop fracture involving triathlon pkr baseplate #4 rm/ll was reported.The event was confirmed based on medical review.Method & results: device evaluation and results: not performed as product remains implanted.Clinician review: a review of the provided medical records and x-rays by a clinical consultant was rejected indicating: "after the operation it was confirmed that the inner condyle of the tibia was fractured.Osteosynthesis scheduled for 4/17.X-rays 2 ap and 2 lat images of right knee labelled in asian language with no date noted in english.A cemented medial uka is present with a fracture of the medial tibial plateau beginning medial to the tibial component andextending distally to exit the medial tibial cortex approximately 5 cm distal to the joint line.With minimal subsidence of the fracture fragment.No clinical or pmh, no patient demographics, no operative reports;imaging studies confirm the event description, but insufficient data is present to create a medical report regarding this event that was most likely the result of surgical technique rather than implant related." device history review: all 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 reported lot.Conclusion: it was reported that after the operation, it was confirmed that the inner condyle of the tibia was fractured.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.Device not returned.

• Brand Name: TRIATHLON PKR BASEPLATE #4 RM/LL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10043745
• Report Number: 0002249697-2020-00893
• Device Sequence Number: 3731902
• Product Code: HRY
• UDI-Device Identifier: 07613327015553
• UDI-Public: 07613327015553
• Combination Product (Y/N): N
• PMA/510(K) Number: K082567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2020

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: 11/30/2024
• Device Model Number: 5620-B-402
• Device Catalogue Number: 5620-B-402
• Device Lot Number: BXA4HA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 07/14/2020
• 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: Hospitalization; Required Intervention