MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 25MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	5537-G-425
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Device not returned.
Event or Problem Description
This was a poly exchange, quad tendon repair, third revision and reimplant of a patella.
Event or Problem Description
This was a poly exchange, quad tendon repair, third revision and reimplant of a patella.
Additional Manufacturer Narrative
An event regarding revision for unspecified reasons involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: the insert was returned for evaluation.Blood is visible on the insert.Explantation damage is visible on the insert.The returned components were reviewed by a material analysis engineer who indicated: damage consistent with articulation against the femoral component was observed on the condyles of the insert.Backside impression markings consistent with contact against a tibial base plate was observed on the distal surface of the insert.Yellow discoloration consistent with synovial fluid absorption was also observed.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 device 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.Conclusion: the insert was returned for evaluation.Blood is visible on the insert.Explantation damage is visible on the insert.The returned components were reviewed by a material analysis engineer who indicated: damage consistent with articulation against the femoral component was observed on the condyles of the insert.Backside impression markings consistent with contact against a tibial base plate was observed on the distal surface of the insert.Yellow discoloration consistent with synovial fluid absorption was also observed.No identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The event cannot be confirmed based on the information provided.Further information such as the reason for the revision surgery, pre- and post-operative x-rays, operative reports as patient history and follow-up notes are required to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 25MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9155934
• Report Number: 0002249697-2019-03385
• Device Sequence Number: 11297451
• Product Code: MBH
• UDI-Device Identifier: 07613327027266
• UDI-Public: 07613327027266
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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: 07/31/2016
• Device Catalogue Number: 5537-G-425
• Device Lot Number: MKK3W3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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