MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CS INS SIZE 6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/MET

Catalog Number	5531P609
Medical Device Problem Codes	Break (1069); Crack (1135); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product 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.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Knee scope for clean out but went to poly exchange because the n2vac poly had fractured on the posteromedial aspect.Update 30-september-2018: as reported: "scheduled knee scope for loose body turned to a poly exchange for a size 6 9 mm tibial bearing insert, n2vac cs.Upped the poly size to 11mm, same type of implant.The poly fractured on the posteromedial aspect of the insert.Cause for fracture unknown to rep and surgeon".
Event or Problem Description
Knee scope for clean out but went to poly exchange because the n2vac poly had fractured on the posteromedial aspect.Update 30-september-2018: as reported: "scheduled knee scope for loose body turned to a poly exchange for a size 6 9 mm tibial bearing insert, n2vac cs.Upped the poly size to 11mm, same type of implant.The poly fractured on the posteromedial aspect of the insert.Cause for fracture unknown to rep and surgeon".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed by material analysis of the returned device.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2018 which indicated.One insert and locking wire were returned for evaluation.Damages were observed on the articulating surface consistent with contact against the femoral component.Damages, consistent with the explantation process, was observed on the anterior and distal surfaces of the insert.Backside impression markings were observed on the distal surface of the insert, indicating proper seating between the insert and baseplate.The posterior end of the lateral condyle had fractured.Wallner lines were observed on the fracture surface, indicting the insert fractured due to an overload condition.Debris was also observed on the insert.Eds (energy-"dispersive" spectroscopy) analysis of the debris included ti-al-v, which are consistent with a titanium-6 aluminum-4 vanadium alloy.Potential sources of the debris include the baseplate and patella implants.Nothing remarkable was observed on the wire.A material analysis has been performed.The report concluded: the posterior end of the lateral condyle had fractured.The fracture was consistent with an overload condition.Burnishing, scratching and third-body indentations were also observed on the insert condyles.These are common damage modes of uhmwpe.Eds showed the samples of debris were consistent with biological material and a titanium-6 aluminum-4 vanadium alloy.Potential sources of the debris include the baseplate and patella implants.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: an event regarding crack/fracture of a triathlon insert was reported.Visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2018 which indicated.One insert and locking wire were returned for evaluation.Damages were observed on the articulating surface consistent with contact against the femoral component.Damages, consistent with the explantation process, was observed on the anterior and distal surfaces of the insert.Backside impression markings were observed on the distal surface of the insert, indicating proper seating between the insert and baseplate.The posterior end of the lateral condyle had fractured.Wallner lines were observed on the fracture surface, indicting the insert fractured due to an overload condition.Debris was also observed on the insert.Eds (energy-"dispersive" spectroscopy) analysis of the debris included ti-al-v, which are consistent with a titanium-6 aluminum-4 vanadium alloy.Potential sources of the debris include the baseplate and patella implants.Nothing remarkable was observed on the wire.A material analysis has been performed.The report concluded: the posterior end of the lateral condyle had fractured.The fracture was consistent with an overload condition.Burnishing, scratching and third-body indentations were also observed on the insert condyles.These are common damage modes of uhmwpe.Eds showed the samples of debris were consistent with biological material and a titanium-6 aluminum-4 vanadium alloy.Potential sources of the debris include the baseplate and patella implants.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CS INS SIZE 6 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/MET
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7960919
• Report Number: 0002249697-2018-03314
• Device Sequence Number: 201957
• Product Code: JWH
• UDI-Device Identifier: 07613327042399
• UDI-Public: 07613327042399
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 5531P609
• Device Lot Number: LEU453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 02/11/2019
• 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: 64 YR