MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CS#6 11MME; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-611-E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The following devices were also listed in this report: triathlon cr fem comp #6 l-cem; cat # 5510f601; lot # hj29y triathlon prim tib baseplate - cemented; cat # 5520-b-600; lot # duz4eb triathlon asymmetric x3 patella; cat # 5551-g-320; lot # d3j5 3.0 rio® robotic arm - mics; cat # 209999; lot # unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Dr (b)(6) reports patient (b)(6) a status post primary left total knee done on (b)(6)2020 appears infected and requests to remove the implants and put in an antibiotic spacer.Dr (b)(6) carefully removed the implants using flexible osteotomes and a saw.He then proceeded to debride and wash the bone.Once removed and washed he implanted an antibiotic spacer made of cement laden with extra antibiotics.The procedure was performed without incident.No further information is available.Correction 01/june/2020 wg: branch provided implant sheets for the robotic primary on (b)(6) 2019 and a poly swap performed on (b)(6) 2020.

• Brand Name: X3 TRIATHLON INSERT CS#6 11MME
• 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: 10152143
• Report Number: 0002249697-2020-01179
• Device Sequence Number: 13965726
• Product Code: MBH
• UDI-Device Identifier: 07613327337341
• UDI-Public: 07613327337341
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2020

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: 10/31/2024
• Device Model Number: 5531-G-611-E
• Device Catalogue Number: 5531G611E
• Device Lot Number: LJN580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/15/2020
• 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: 77 YR
• Patient Weight: 99