MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-616
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	06/28/2017
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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not available.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to painful and unstable left total knee arthroplasty.
Additional Manufacturer Narrative
Reported event: an event regarding revision due to instability involving triathlon insert as reported.The event was confirmed via clinician review.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the revision of a left total knee arthroplasty about 4 years after implantation due to instability.I can confirm that this event took place since i was able to review the revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of instability are multifactorial including surgical technique factors, patient factors such as activity level, bmi, and trauma.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other similar event for the reported lot.Conclusion: it was reported that patient was revised due to painful and unstable left total knee arthroplasty whereby the 16mm cs insert was revised with a 19mm cs insert.The event was confirmed via clinician review.The exact cause of event cannot be determined.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to painful and unstable left total knee arthroplasty.*update on 11-march-2022 per medical review: "[.] june 28, 2017: there is in operation report from dr.The pre-and postop diagnosis was painful and unstable left total knee arthroplasty.The operation performed was a revision left total knee arthroplasty.The implants utilized were a stryker triathlon x3 19 mm polyethylene insert cs size #6.Operative findings included well fixed implants, no patella wear, mild posterior medial tibial insert wear, a flexion gap that was equal in size to the extension gap, competent posterior cruciate ligament, femoral axial rotation slightly external to the tibia with the tibial rotation at the junction of the medial and middle third of the tibial tubercle.There was clear yellow fluid present but no evidence of infection.A 19 mm cs insert provided satisfactory stability according to the surgeon.[.]".

• Brand Name: X3 TRIATHLON CS INSERT #6 16MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 10842680
• Report Number: 0002249697-2020-02463
• Device Sequence Number: 19766222
• Product Code: MBH
• UDI-Device Identifier: 07613327045987
• UDI-Public: 07613327045987
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: 09/30/2015
• Device Model Number: 5531-G-616
• Device Catalogue Number: 5531G616
• Device Lot Number: LCA689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male