MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CS INS SIZE 3 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531P309
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
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.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
The customer reported that the during a total knee replacement post insertion a metal wire became detached from the poly insert.The product was removed form the patient.Case was completed using a triathlon cr tibial insert #3/9mm used ¿instead of cs insert.
Event or Problem Description
The customer reported that the during a total knee replacement post insertion a metal wire became detached from the poly insert.The product was removed form the patient case was completed using a triathlon cr tibial insert #3/9mm used ¿instead of cs insert.
Additional Manufacturer Narrative
An event regarding seating/locking issue involving a triathlon insert was reported.The event was confirmed through visual analysis of the provided photograph.Conclusions: the customer reported that the during a total knee replacement post insertion a metal wire became detached from the poly insert.The reported device was not returned however photographs were provided for review.The photograph shows a recently explanted triathlon insert with the locking wire detached.Based on the photograph provided, it appears that the wire is slightly bent.This damage is consistent with attempted implantation and subsequent explantation of the device.No further investigation is required at this time.If additional information becomes available, this record will be reopened.

• Brand Name: TRIATHLON CS INS SIZE 3 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
• MDR Report Key: 7912274
• Report Number: 0002249697-2018-03104
• Device Sequence Number: 2305247
• Product Code: MBH
• UDI-Device Identifier: 07613327042160
• UDI-Public: 07613327042160
• Combination Product (Y/N): N
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 5531P309
• Device Lot Number: LHF 183
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 11/21/2018
• 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: 70 YR