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-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "pt.Presented with a draining surgical-wound.Ts+ insert was swapped out as part of dr¿s i & d protocol.No complaints have been made against the implants themselves." spoke to rep, who provided the revision usage sheet.A 5x11 ts insert was exchanged for another of the same catalog number.
Additional Manufacturer Narrative
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.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12819549
• Report Number: 0002249697-2021-01906
• Device Sequence Number: 18490266
• Product Code: MBH
• UDI-Device Identifier: 07613327288315
• UDI-Public: 07613327288315
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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 Model Number: 5537-G-511-E
• Device Catalogue Number: 5537-G-511-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male