MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CS INS SIZE 6 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-P-613
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Injury (2348)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
Defective knee prosthesis posterior medial.Update august 27, 2020: right knee revision of a primary triathlon poly.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed by clinician review.Method & results: product evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: the available medical records were provided for a review to the consulting clinician, " adverse event identified -revision of polyethylene in uncemented triathlon knee 6 year postoperative.Hazards: a "fracture" and "defect" in the polyethylene were noted.Conclusion of assessment: a revision of a triathlon polyethylene was performed at 6 years postoperatively.'the documents provided did not present a clear picture of the events.A fracture or defect in the polyethylene was noted.'there was an apparent fall with trauma that may have been the inciting factor.Obtaining the polyethylene for examination as well as additional medical records may provide additional insights into the event." device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: it was reported that the patient had a revision.The available medical records were provided for a review to the consulting clinician which concluded that a revision of a triathlon polyethylene was performed at 6 years postoperatively.The documents provided did not present a clear picture of the events.A fracture or defect in the polyethylene was noted.There was an apparent fall with trauma that may have been the inciting factor.Obtaining the polyethylene for examination as well as additional medical records may provide additional insights into the event.No further investigation for this event is possible.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Defective knee prosthesis posterior medial.Update august 27, 2020: right knee revision of a primary triathlon poly.

• Brand Name: TRIATHLON CS INS SIZE 6 13MM
• 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: 10507186
• Report Number: 0002249697-2020-01812
• Device Sequence Number: 1270538
• Product Code: MBH
• UDI-Device Identifier: 07613327042375
• UDI-Public: 07613327042375
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2021

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 Model Number: 5531-P-613
• Device Catalogue Number: 5531P613
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 01/10/2021
• 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: 70 YR
• Patient Weight: 110