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

Catalog Number	5530-G-409
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	03/07/2019
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.
Event or Problem Description
Right knee washout & poly insert exchange for infection (b)(6) 2019.History: right total knee replacement (b)(6) 2014.Right patella resurfacing (b)(6) 2017.Patient fell onto right knee around (b)(6) 2019.Presented with damaged quadriceps surgery to repair (b)(6) 2019.At this surgery infection noted.Specimens sent to pathology for analysis.(b)(6) grown.
Additional Manufacturer Narrative
An event regarding infection involving a triathlon insert was reported.The event was confirmed based on the medical records provided.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided records by a clinician indicated: no imaging studies and no id consult documents or confirming bacteriologic studies are available for review.There is no indication the periprosthetic infection in this twice operated upon right knee was related to the design, manufacturing or materials of the total knee arthroplasty components.Device history review: 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 reported lot or sterile lot.Conclusion: while the event could be confirmed based on medical records provided, the exact cause of the event could not be determined because insufficient information was provided.Additional information: including imaging studies and no id consult documents or confirming bacteriologic studies and return of the device are needed to fully investigate the event.A microbiological assessment was completed by principal microbiologist, stryker ireland who indicated: due to the nature of the organism isolated - susceptible to various modes of sterilization - and the sterilization methodology employed by stryker, it is not probable that mrsa could have originated from the implants.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Right knee washout & poly insert exchange for infection (b)(6) 2019.History: right total knee replacement (b)(6) 2014.Right patella resurfacing (b)(6) 2017.Patient fell onto right knee around (b)(6) 2019.Presented with damaged quadriceps surgery to repair (b)(6) 2019.At this surgery infection noted.Specimens sent to pathology for analysis mrsa grown.

• Brand Name: TRIATHLON CR 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: 8482338
• Report Number: 0002249697-2019-01528
• Device Sequence Number: 1962412
• Product Code: MBH
• UDI-Device Identifier: 07613327050479
• UDI-Public: 07613327050479
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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: 05/31/2019
• Device Catalogue Number: 5530-G-409
• Device Lot Number: MNHK9X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 07/09/2019
• 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: 64 YR
• Patient Weight: 90