MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-316
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, 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 sz4 right; 5512-f-402; swzp; tri ts baseplate size 3; 5521-b-300; mzbod; dura duration all poly pat xsm; 6642-2-040; 00515424; triathlon femoral distal augment 5mm - size 4 right; 5540-a-402; tbpw; tri press-fit stem 12mm x 100mm; 5565-s-012; m9a3j; tri press-fit stem 17mm x 100mm; 5565-s-017; 0034135a; triathlon sym cone aug sz b; 5549-a-120; a604.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not available.
Event or Problem Description
This pi is for the poly swap with i&d on (b)(6) 2020: procedure: the patient had difficulties with the right knee due to mechanical failure.Patient underwent a revision of the right total knee replacement (b)(6) 2013.Patient underwent right knee revision to treat the pain all components exchanged in (b)(6) 2015 reported as cors per 1473knee.Patient underwent right total knee replacement with revision of poly insert and incision and drainage and synovectomy for right infected total knee replacement (b)(6) 2020.

• Brand Name: NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM
• 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: 10459229
• Report Number: 0002249697-2020-01749
• Device Sequence Number: 2939130
• Product Code: MBH
• UDI-Device Identifier: 07613327027150
• UDI-Public: 07613327027150
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: 09/01/2019
• Device Model Number: 5537-G-316
• Device Catalogue Number: 5537-G-316
• Device Lot Number: MNNT3N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/27/2020
• 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: 75 YR
• Patient Weight: 115