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

Catalog Number	5532-G-709
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Post Operative Wound Infection (2446)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding a patient experiencing wound complications post tka involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no product was not returned for evaluation.Medical records received and evaluation: not performed as medical records were not provided.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 reported lot referenced.Conclusion: it is reported that a patient experienced wound complications post tka.It was confirmed by the surgeon that there was no infection present.It is noted that the patient is on anti cancer drugs that contributed to the wound breakdown.The exact cause of the event could not be determined as insufficient information was provided.Further information such as product return, primary and revision operative reports and pre-revision x-rays are needed to complete the investigation for determining root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.
Event or Problem Description
Patient had a primary total knee (b)(6) 2018.Patient showed up for follow up with wound complications.Patient was taken to the or for a suspected infection.Surgeon noted the wound was clean but had some necrotic tissue.The poly was exchanged as a precaution.Surgeon also noted that the patient was on anti cancer drugs that contributed to the wound breakdown.Wound was copiously irrigated and the poly exchanged successfully.Update (b)(4) 2018: spoke to rep.Infection was not confirmed by pathology but surgeon reported that he felt there was no infection.Rep provided primary and revision implant sheets, and reported that no additional information is available due to hospital policy.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8210226
• Report Number: 0002249697-2019-00013
• Device Sequence Number: 264852
• Product Code: MBH
• UDI-Device Identifier: 07613327046274
• UDI-Public: 07613327046274
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

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: 03/31/2023
• Device Catalogue Number: 5532-G-709
• Device Lot Number: J43LN4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 01/02/2019
• 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: 69 YR
• Patient Weight: 91