MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/04/2021
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: tri ts femur sz5 left; cat # 5512-f-501; lot # xsij, tri press-fit stem 17x150mm; cat # 5566-s-017; lot # m4k14f, triathlon femoral distal augment 5mm - size 5 left; cat # 5540-a-501; lot # ybmt, triathlon femoral distal augment 5mm - size 5 left; cat # 5540-a-501; lot # xwdv, tri post augment sz5 5mm; cat # 5543-a-500; lot # yfrm, tri ts baseplate size 5; cat # 5521-b-500; lot # zpzl, tri press-fit stem 16x150mm; cat # 5566-s-016; lot # m3v24d, triathlon stem extender 25mm; cat # 5571-s-025; lot # n3w20d, triathlon total knee system offset adapter 4mm; cat # 5570-s-040; lot # m4n03g.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Removal of triathlon ts right total knee arthroplasty due to infected knee.

• Brand Name: NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 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: 11398690
• Report Number: 0002249697-2021-00360
• Device Sequence Number: 13773998
• Product Code: MBH
• UDI-Device Identifier: 07613327027297
• UDI-Public: 07613327027297
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

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: 04/30/2014
• Device Model Number: 5537-G-511
• Device Catalogue Number: 5537-G-511
• Device Lot Number: MHER3V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/02/2021
• 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: 85 YR
• Patient Weight: 63