MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	5531G713
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/28/2013
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, it will be provided in a supplemental report upon completion of the investigation the following devices were also listed in this report: triathlon cr fem comp #6 l-cem; cat#5510f601; lot#sp4py; tri ts baseplate size 7; cat#5521-b-700; lot#ffyt; tri press-fit stem 16mm x 100mm; cat#5565-s-016; lot#m5c14z; simplex p - us tobra fd 10-pk; cat#61979010; lot#mjs070; simplex p - us tobra fd 10-pk; cat#61979010; lot#mjs070.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
This pi is for the revision of patient's left knee on (b)(6) 2013.It was reported through the submission of five implant sheets on (b)(6) 2018 that patient's left knee was revised on (b)(6) 2013.A cr femur (implanted (b)(6) 2010), baseplate, stem and 2 doses of cement (implanted (b)(6) 2011), and a cs insert (implanted (b)(6) 2011) were revised to a triathlon ts construct consisting of a femur, 2 stems, universal baseplate, and insert.

• Brand Name: X3 TRIATHLON CS INSERT #7 13MM
• 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: 7897728
• Report Number: 0002249697-2018-02996
• Device Sequence Number: 1312082
• Product Code: JWH
• UDI-Device Identifier: 07613327046014
• UDI-Public: 07613327046014
• 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: 2011
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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: 09/30/2016
• Device Catalogue Number: 5531G713
• Device Lot Number: LCP596
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/21/2018
• 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: 58 YR
• Patient Weight: 151