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

Catalog Number	5532-G-213
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/03/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon asymmetric x3 patella; cat# 5551-g-320; lot# 988h; triathlon ps fem component, cemented; cat# 5515-f-302; lot# gxmjd; tri ts baseplate size 2; cat# 5521-b-200; lot# bsdi.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.Device not available.
Event or Problem Description
This pi is for right knee.It was reported through the communication of an attorney that allegedly the patient was revised due to a failed right total knee arthroplasty.
Event or Problem Description
This pi is for right knee it was reported through the communication of an attorney that allegedly the patient was revised due to a failed right total knee arthroplasty.
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon baseplate was reported.The event was confirmed through clinician review of provided medical records.Method & results product evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: there is some information available in the medical records to suggest that component malposition has played a relevant role in the failure mode of this triathlon ps arthroplasty due to fixation failure.Lack of x-ray availability at this time prevents to establish this with more certainty.Product history review: indicated 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: a review of the provided medical records and x-rays by a clinical consultant indicated: there is some information available in the medical records to suggest that component malposition has played a relevant role in the failure mode of this triathlon ps arthroplasty due to fixation failure.Lack of x-ray availability at this time prevents to establish this with more certainty.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: 8964783
• Report Number: 0002249697-2019-03101
• Device Sequence Number: 13975267
• Product Code: MBH
• UDI-Device Identifier: 07613327046236
• UDI-Public: 07613327046236
• 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: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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: 11/30/2016
• Device Catalogue Number: 5532-G-213
• Device Lot Number: LCR815
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 11/27/2019
• 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: 53 YR