MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; ROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COA

Catalog Number	5530-G-411
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	01/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding infection and a range of motion issue involving a triathlon insert component was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: pending.Product history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, such as pathology reports including detail of the strain of infection, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.The following devices were also listed in this report: tritanium bplate triathlon s4; cat#5536b400; lot#ctd3665.Triathlon mb patella pa a32; cat#5554l320; lot#ebf7j.Triathlon p/a cr beaded #4l; cat#5517f401; lot#ehs6s.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 a debridement and poly swap was performed on patient's left knee due to suspected infection.Surgeon reported that patient had a recent urinary tract infection and suspects it as a possible cause/ contributor.It was not reported to the rep if the infecting microorganism was clinically confirmed or identified.A 4x11 cr insert was revised to a 4x9 cr insert as the surgeon also felt the patient's knee was a little too tight.
Additional Manufacturer Narrative
Reported event: an event regarding infection and a range of motion issue involving a triathlon insert component was reported.The event was confirmed.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.-clinician review: review of these records confirm i&d with tibial component liner exchange because of suspected infection.The root cause of the infection cannot be determined as insufficient information was available.Documentation which would aid in the further completion of this assessment would include: outpatient office/clinic notes, laboratory reports, microbiology, pathology reports.-product history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, such as outpatient office/clinic notes, laboratory reports, microbiology, pathology reports are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that a debridement and poly swap was performed on patient's left knee due to suspected infection.Surgeon reported that patient had had a recent urinary tract infection and suspects it as a possible cause/ contributor.It was not reported to the rep if the infecting microorganism was clinically confirmed or identified.A 4x11 cr insert was revised to a 4x9 cr insert as the surgeon also felt the patient's knee was a little too tight.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Common Device Name: ROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COA
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8302247
• Report Number: 0002249697-2019-00429
• Device Sequence Number: 1663271
• Product Code: MBH
• UDI-Device Identifier: 07613327050486
• UDI-Public: 07613327050486
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 04/02/2019

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: 11/30/2018
• Device Catalogue Number: 5530-G-411
• Device Lot Number: MMRKJY
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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: 67 YR