MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G313
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon cr fem comp #3 l-cem; cat# 5510f301; lot# efa3p; triathlon prim tib baseplate - cemented; cat# 5520-b-300; lot# ehhyn; triathlon asymmetric x3 patella; cat# 5551-g-320; lot# md3w.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.Device not returned.
Event or Problem Description
Covered revision of a triathlon lt tka originally implanted (b)(6) 2014.Knee was found to be infected.All implants were removed and antibiotic spacer was implanted.Patient requested to keep removed implants and did.

• Brand Name: X3 TRIATHLON CS INSERT #3 13MM
• 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: 8608817
• Report Number: 0002249697-2019-01934
• Device Sequence Number: 13955944
• Product Code: MBH
• UDI-Device Identifier: 07613327045741
• UDI-Public: 07613327045741
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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: 08/31/2015
• Device Catalogue Number: 5531G313
• Device Lot Number: LBZ306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/14/2019
• 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: 70 YR
• Patient Weight: 80