MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532-G-609

Device Problems Device Abrasion From Instrument Or Another Object (1387); Defective Device (2588); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It has been reported that the reference 5532-g-609 tibial bearing insert 6/9mm seems to have a defect.

Manufacturer Narrative

An event regarding fitting issue involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: the device was returned in damage condition.The anterior bearing surface of the insert shows minor pitting and light scratches consistent with short clinical use.The locking wire found disassemble from the insert.Examination of the returned device with material analysis engineer indicated that damage on the anterior surface of the insert at the location of the locking wire.Damage likely allowed locking wire to disassemble from the insert.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed as the device was returned in damage condition.Material analysis engineer indicated that the damage observed at the location of the locking wire which likely allowed locking wire to disassemble from the insert.Due to this, functional and dimensional test could not be performed.Thus, the exact cause of fitting issue could not be determined.If additional information becomes available, this investigation will be reopened.

Event Description

It has been reported that the reference (b)(4) tibial bearing insert 6/9mm seems to have a defect.Our customer has reported that the defect is: the metallic part was defective and the polyethylene did not fit into the tibial base.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6213609
• MDR Text Key: 63804786
• Report Number: 0002249697-2016-04052
• 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: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2017

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: 12/31/2020
• Device Catalogue Number: 5532-G-609
• Device Lot Number: YT5MVK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2015
• 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
• Patient Age: 76 YR