MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5536B300

Device Problem Osseointegration Problem (3003)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Removing cemented tritanium baseplate that is loose.Update 30/april/2019: as reported in how was issue noticed: patient complained of pain.

Event Description

Removing cemented tritanium baseplate that is loose.Update 30/april/2019: as reported in how was issue noticed: patient complained of pain.

Manufacturer Narrative

An event regarding loosening involving a triathlon baseplate was reported.The event was confirmed through clinician review of the provided x-rays.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: provided x-ray confirms the reported event.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.-product history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: the event of loosening was confirmed through review of the provided x-rays.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as operative reports, office/clinical reports, serial x-rays, and examination of the explanted components 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.

• Brand Name: TRITANIUM BPLATE TRIATHLON S3
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8637816
• MDR Text Key: 145990238
• Report Number: 0002249697-2019-02090
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041484
• UDI-Public: 07613327041484
• 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
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2023
• Device Catalogue Number: 5536B300
• Device Lot Number: CTD23495
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 07/23/2019
• Supplement Dates FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR