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

Device Problems Mechanical Problem (1384); Difficult To Position (1467); Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584); Positioning Problem (3009)

Patient Problems Injury (2348); No Information (3190)

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Original poly impaction was attempted, dr.(b)(6) attempted to impact numerous times and the poly refuse to lock into baseplate.Only 1 poly of that size was available so the doctor chose to go down 1 size and the poly was impacted and locked into baseplate on first try.

Manufacturer Narrative

An event regarding a no 4.Triathlon ts plus tibial insert x3 poly 13mm not locking into a baseplate during primary surgery was reported.The event was confirmed.Method & results: - device evaluation and results: the tibial insert was returned in used condition.There were minor nicks and burrs throughout, small indentations near the stem and on the bottom, and damage to one corner.The observed damage indicates the tibial insert was not positioned properly in te baseoplate prior to impaction (the tibial insert was not seated under the lip of the baseplate).Subsequent impactions resulted in further deformation of the tibial insert.- medical records received and evaluation: no medical records were received for review with a clinical consultant.- device history review: device history review confirmed all devices accepted into finished goods conformed to specification.- complaint history review: no other events were reported for the lot indicated.Conclusions: the tibial insert displayed small indentations near the stem and on the bottom, minor nicks and burrs throughout, and damage to one corner.The observed damage indicates the tibial insert was not positioned properly in te baseoplate prior to impaction (the tibial insert was not seated under the lip of the baseplate).Subsequent impactions resulted in further deformation of the tibial insert.Inspection by stryker material analysis confirmed that these indentations, nicks and burrs were consistent with indications of an unsuccessful insertion (attempted locking) of the tibial insert into the baseplate.

Event Description

Original poly impaction was attempted, dr.(b)(6) attempted to impact numerous times and the poly refuse to lock into baseplate.Only 1 poly of that size was available so the doctor chose to go down 1 size and the poly was impacted and locked into baseplate on 1st try.

• Brand Name: NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM
• Type of Device: 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5195937
• MDR Text Key: 30476694
• Report Number: 0002249697-2015-03552
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/05/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 5537-G-413
• Device Lot Number: MNH643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2015
• Initial Date FDA Received: 11/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2014
• 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
• Patient Age: 62 YR
• Patient Weight: 70