MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/05/2021
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: cat #: 5510f401; triathlon cr fem comp #4 l-cem; lot #: cr93s.Cat #: 5520-b-400; triathlon prim tib baseplate - cemented; lot # bia9ob.Cat #: 5551-g-320; triathlon asymmetric x3 patella; lot # a6h2.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.Revised a triathlon cs insert originally done with mako on (b)(6) 2019 due to infection.Left knee.He upsized from a 4x11 to a 4x12 while he was in doing the i&d because he said it felt better.Update (b)(6) 2021: rep provided primary and revision usage sheets and reported that no further information is available from the hospital or surgeon.

• Brand Name: X3 TRIATHLON CS INS SIZE4 11MM
• 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: 11242139
• Report Number: 0002249697-2021-00177
• Device Sequence Number: 17022301
• Product Code: MBH
• UDI-Device Identifier: 07613327045789
• UDI-Public: 07613327045789
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2021

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: 05/31/2024
• Device Model Number: 5531-G-411
• Device Catalogue Number: 5531G411
• Device Lot Number: LJF253
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/28/2021
• 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: 71 YR