MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK X3 TRIATHLON CS INSERT #6 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-609
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Addition devices: catalog numbers and lot codes of other devices listed in this report: triathlon prim tib baseplate - cemented; 5520-b-600; drd4vb.Triathlon cr fem comp #6 l-cem; 5510f601; dln3c.Triathlon asymmetric x3 patella; 5551-g-401; 7075.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Rep reported: "left total knee revision performed patient presented with an infected tka, original surgery performed in october of last year.Explants are not available for return as per hospital policy." a 7x 13 mm ps tibial component, size 6 ps femoral component, and size a40 asymmetric patella were implanted.Rep confirmed no other information will be released by hospital or surgeon.

• Brand Name: X3 TRIATHLON CS INSERT #6 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• MDR Report Key: 10662818
• Report Number: 0002249697-2020-02101
• Device Sequence Number: 17025173
• Product Code: MBH
• UDI-Device Identifier: 07613327045932
• UDI-Public: 07613327045932
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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 Model Number: 5531-G-609
• Device Catalogue Number: 5531G609
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/12/2020
• 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: 61 YR