MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 5537-G-413

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

It is reported by dr.(b)(6), surgeon of the hospital that the inlay could not be anchored.Replacement was available.Surgical delay of 15 minutes.

Manufacturer Narrative

An event involving a no.4 triathlon ts plus tibial insert x3 poly 13mm was reported.The event was confirmed.Method & results: -device evaluation and results: a discussion with the mar group, concluded based on a visual inspection, the damage to the post was likely from explantation of the device since it would not anchor into the baseplate.The underside of the liner by the locking wire shows indents which indicate the front locking mechanisms did not engage therefore causing the back edge of the liner to rub against the edge of the baseplate.-medical records received and evaluation: not performed as no medical records were provided.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the investigation concluded that a visual inspection by the mar group found, ¿the underside of the liner by the locking wire shows indents which indicates the front locking mechanisms did not engage therefore causing the back edge of the liner to rub against the edge of the baseplate.¿ the investigation concluded potential user error as the cause of the event.

Event Description

It is reported by dr.(b)(6) surgeon of the hospital that the inlay could not be anchored.Replacement was available.Surgical delay of 15 minutes.

• Brand Name: NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5758630
• MDR Text Key: 48476886
• Report Number: 0002249697-2016-02079
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 5537-G-413
• Device Lot Number: 7V8DV7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other