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

Catalog Number	5532-G-611
Medical Device Problem Codes	Break (1069); Degraded (1153)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's right knee was revised after patient presented with a complaint in (b)(6) 2018 (nature of the complaint not reported to rep).Intra-operatively, the tip of the device was broken off and one side was worn.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon insert was reported.Material analysis of the returned device confirmed the event.Method & results: product evaluation and results: visual inspection of the returned device noted the following: damage was observed on this distal side of the insert consistent with explantation.Backside impressions were observed on the distal side of the insert consistent with contact against a tibial baseplate.Damage was observed on the articulating surface of the insert, consistent with contact against the femoral component.Damage on the articulating surface is consistent with delamination, burnishing, scratching, and third body indentations; these are common damage modes of uhmwpe reference 1.Yellow discoloration consistent with absorption of synovial fluid was also observed on the insert reference 2.The proximal fracture surface morphology is consistent with an overload fracture initiating on the posterior surface and propagating anteriorly.The fracture surface morphology is consistent with an overload fracture initiating on the posterior surface and propagating anteriorly.Damage on the posterior surface of the fractured post is consistent with delamination, scratching, third body indentations, and pitting; these are common damage modes of uhmwpe reference 1.Medical records received and evaluation: a review of the provided operative reports, x-rays, office notes and explant photos by a clinical consultant revealed: in this large male patient, likely repeated impingement of the ps poly post on the femoral component at the extremes of motion resulted in fatigue fracture of the post.Examination of the fracture surfaces and insert would confirm this mechanism and rule out factors associated with materials or manufacturing as having contributed to this late clinical event.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the medical review revealed the following: in this large male patient, likely repeated impingement of the ps poly post on the femoral component at the extremes of motion resulted in fatigue fracture of the post.Examination of the fracture surfaces and insert would confirm this mechanism and rule out factors associated with materials or manufacturing as having contributed to this late clinical event.The device was returned and material analysis carried out.This report concluded the following: the tibial post fractured in overload with the fracture initiating on the posterior surface and propagating anteriorly.The damage present on articulating surface of the insert is consistent with contact against the femoral component.The damage modes, delamination, scratching, and third body indentations, are common of uhmwpe reference 1.Yellow discoloration consistent with absorption of synovial fluid was also observed on the insert reference 2.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right knee was revised after patient presented with a complaint in (b)(6) 2018 (nature of the complaint not reported to rep).Intra- operatively, the tip of the device was broken off and one side was worn.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8471880
• Report Number: 0002249697-2019-01497
• Device Sequence Number: 1955369
• Product Code: MBH
• UDI-Device Identifier: 07613327050851
• UDI-Public: 07613327050851
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: 11/30/2013
• Device Catalogue Number: 5532-G-611
• Device Lot Number: MERJXK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 07/25/2019
• 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: 68 YR
• Patient Weight: 116