MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	5530-G-509
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2012
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.The following devices were also listed in this report: triathlon asymmetric x3 patella;5551-g-350;841b.Triathlon cr fem comp #6 l-cem;5510f601;k1105.Triathlon prim cem fxd bplt #5;5520b500;jb120.Simplex p full dose 1 pack;6191-1-001;rfp139.Simplex p with tobramycin 1 pack;6197-9-001;mkp056.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 through the communication of an attorney that allegedly the patient was revised due to failed left knee arthroplasty.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10841557
• Report Number: 0002249697-2020-02454
• Device Sequence Number: 4135394
• Product Code: JWH
• UDI-Device Identifier: 07613327050530
• UDI-Public: 07613327050530
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2020

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: 08/31/2013
• Device Model Number: 5530-G-509
• Device Catalogue Number: 5530-G-509
• Device Lot Number: V82MLE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/15/2020
• 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: 36 YR