MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-413
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	02/06/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: tri ts baseplate size 4; cat# 5521-b-400; lot# frd, triathlon total knee system offset adapter 6mm; cat# 5570-s-060; lot# m3w40am, tri press-fit stem 16mm x 100mm; cat# 5565-s-016; lot# m6s43j, triathlon total knee system offset adapter 4mm; cat# 5570-s-040; lot# m6m13a, triathlon femoral distal augment 5mm - size 4 left; cat# 5540-a-401; lot# dzjr, tri press-fit stem 15mm x 100mm; cat# 5565-s-015; lot# m4c20e, triathlon femoral distal augment 5mm - size 4 left; cat# 5540-a-401; lot# duxj, tri ts femur sz4 left; cat# 5512-f-401; lot# edil.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been two 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.
Event or Problem Description
Based on the medical review, on (b)(6) 2013, a rom of only 0° to 30° was reported.Patient could not walk around, required a lot of strong pain medication including oxycontin.This second left knee revision surgery was performed on (b)(6) 2013, again on the indication of arthrofibrosis.No report of bearing exchange at this time.

• Brand Name: NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM
• 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: 9361750
• Report Number: 0002249697-2019-03847
• Device Sequence Number: 2606401
• Product Code: MBH
• UDI-Device Identifier: 07613327027242
• UDI-Public: 07613327027242
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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: 02/28/2016
• Device Catalogue Number: 5537-G-413
• Device Lot Number: MKD6PY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/22/2019
• 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: Other
• Patient Age: 60 YR