MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CS #4 12MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Model Number	5531-G-412-E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.The following devices were also listed in this report: 5510f502 triathlon cr fem comp #5 r-cemhyt4n; 5520-b-400 triathlon prim tib baseplate - cemented gdd4ua; 5551-g-320 etriathlon asymmetric x3 patellavmjh.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
The 4x12 cs was removed during i&d for infection.No claims made against device.

• Brand Name: X3 TRIATHLON INSERT CS #4 12MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10897765
• Report Number: 0002249697-2020-02530
• Device Sequence Number: 16760597
• Product Code: JWH
• UDI-Device Identifier: 07613327390360
• UDI-Public: 07613327390360
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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 Expiration Date: 07/31/2024
• Device Model Number: 5531-G-412-E
• Device Catalogue Number: 5531-G-412-E
• Device Lot Number: KR2457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/24/2020
• 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: 65 YR