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-609
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	03/15/2019
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.Device not returned.
Event or Problem Description
Revision of right knee due to possible infection.Sales rep provided x-rays, primary and revision implant sheets and reported that no further information is available.
Additional Manufacturer Narrative
An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: re (b)(6): which represents a 71 y/o male who underwent a right tka on (b)(6) 19 which was revised on (b)(6) 19.The event description states: "revised right knee due to possible infection" undated x-rays include an ap and lateral of the right knee demonstrating a cemented tka with components in nominal position and skin staples in situ.No pathology is demonstrated.A listing of components include: triathlon cemented ps femoral component, #6 tibial baseplate, x3 triathlon ps tibial insert, and triathlon x3 symmetric patellar component.No clinical or past medical history, no patient demographics, no operative reports, and no bacteriology results available for review or serial dated x-rays.Based upon the information available for review, no confirmation of the event description is possible, and if the alleged early post-operative infection occurred, there is no reason to believe it was related to factors of implant design, manufacturing or material.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.There have been no other similar events for the sterile lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed 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.The following devices were also listed in this report: triathlon ps fem component, cemented; cat# 5515-f-602; lot# dd73ra.Tri ts baseplate size 6; cat# 5521-b-600; lot# de97xa.Triathlon symmetric x3 patella; cat# 550-g-391; lot# 8988.It cannot be determined which, if any of these devices may have caused or contributed to the patients experience.
Event or Problem Description
Revision of right knee due to possible infection.Sales rep provided x-rays, primary and revision implant sheets and reported that no further information is available.

• 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: 8522734
• Report Number: 0002249697-2019-01643
• Device Sequence Number: 2798297
• Product Code: MBH
• UDI-Device Identifier: 07613327050844
• UDI-Public: 07613327050844
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/20/2019

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: 10/31/2023
• Device Catalogue Number: 5532-G-609
• Device Lot Number: 00796418D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 11/20/2019
• 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: 71 YR