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-611
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	05/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: not performed as no medical records were provided for review.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 or sterile lot referenced.Conclusion: the event itself could not be confirmed nor could the exact cause of the event be determined because insufficient information was provided.Further information such as product return, pre and post operative x rays, operative reports, pathology report including the strain of infection identified, patient history and follow up notes are needed to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: triathlon ps fem comp #7l-cem; 5515-f-701; cbe2n, triathlon prim tib baseplate - cemented; 5520-b-600; va4ha, triathlon asymmetric x3 patella; 5551-g-381; 6e6v, it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that patient's left knee was revised due to infection (infection reported by surgeon, unknown if clinically identified, rep reported knee was "full of pus").All primary implants were removed and replaced with a cement spacer.

• 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: 7592155
• Report Number: 0002249697-2018-01784
• Device Sequence Number: 232441
• Product Code: MBH
• UDI-Device Identifier: 07613327050851
• UDI-Public: 07613327050851
• 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: 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): 06/12/2018

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: 12/31/2020
• Device Catalogue Number: 5532-G-611
• Device Lot Number: TT8VEW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/12/2018
• 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: 57 YR