MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #2; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 5520B200

Device Problems Material Erosion (1214); Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Dr (b)(6) from the hospital reported to mr (b)(6), rsm joint replacement the following event: "i had a call from dr (b)(6) on wednesday afternoon for an unusually worn pe x3 triathlon implant.I recovered the implant yesterday and actually there is a big wear for a 1 year bp.

Manufacturer Narrative

An event regarding revision involving a triathlon baseplate was reported.The event was confirmed through return of the device.Method & results: device evaluation and results: one baseplate with catalog number 5520b200 and lot code bdc4p was returned for evaluation.Bone cement with some biological matter is visible on the fixation side/underside of the baseplate.Damage on the rim of the fixation side is observed this damage is possibly explantation damage.The material analysis reported concluded: a material analysis has been performed.The report concluded: damage was observed on the condyles of the femoral component, consistent with contact against a hard object.Burnishing, scratching and third-body indentations were observed on the insert condyles.These are common damage modes of uhmwpe.Eds analysis showed the femoral component and baseplate were consistent with astm f75 alloy.Biological fixation was observed on the femoral component and baseplate.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant 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 have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including the reason for revision of the baseplate, operative reports, progress notes, x-rays as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Dr m from the hospital reported to mr j espagnac, rsm joint replacement the following event: "i had a call from dr m on wednesday afternoon for an unusually worn pe x3 triathlon implant.I recovered the implant yesterday and actually there is a big wear for a 1 year bp.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #2
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7803728
• MDR Text Key: 117828808
• Report Number: 0002249697-2018-02633
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041569
• UDI-Public: 07613327041569
• 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
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 5520B200
• Device Lot Number: BDC4P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention