MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-409
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent left index tka outside cors scope.Patient presents with pain and is studied for infection.She is revised for pain and tibial loosening on (b)(6) 2021.All components were exchanged.Patient persists with pain and signs of infection, she is revised again for pji on (b)(6) 2021.Only poly was exchanged.
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.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.The following devices were also listed in this report: tri ts femur sz3 left; cat # 5512-f-301; lot # bix3x, tri ts baseplate size 4; cat # 5521-b-400 ; lot # glx4ba, triathlon symmetric x3 patella; cat # 5550-g-319-e ; lot # v3ej, triathlon ctrfemconeaug sz3&4l; cat # 5549-a-641 ; lot # khnl, triathlon sym cone aug sz e; cat # 5549-a-150 ; lot # p0ep1, tri cemented stem 12mm x 100mm; cat # 5560-s-212 ; lo t# 0090867e, tri post augment sz3 5mm; cat # 5543-a-300 ; lot # gsg7i, triathlon femoral distal augment 10mm - size 3 left; cat # 5541-a-301 ; lot # ghu4r, tri cemented stem 9mm x 100mm; cat # 5560-s-209 ; lot # 0113131h.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned to the manufacturer.

• Brand Name: NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM
• 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: 13752571
• Report Number: 0002249697-2022-00382
• Device Sequence Number: 20100952
• Product Code: MBH
• UDI-Device Identifier: 07613327027211
• UDI-Public: 07613327027211
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2022

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: 02/28/2023
• Device Model Number: 5537-G-409
• Device Catalogue Number: 5537-G-409
• Device Lot Number: J06M91
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2018
• 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: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White