MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520-B-300

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Injury (2348)

Event Date 10/22/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 20-oct-2017 with no relevant reported discrepancies.There have been no other similar events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Revision of a triathlon tibial component was undertaken as it was loose.It was not thought to be infected.

Manufacturer Narrative

An event regarding loosening involving a triathlon baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection of the returned baseplate device was performed.The device appears consistent with an explanted device with no bone cement remaining adhered to it.There is no damage noted on the component.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: need operative reports, histopathology reports, serial x-rays, office reports and examination of explanted components.-device history review: 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 reported lot.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: need operative reports, histopathology reports, serial x-rays, office reports and examination of explanted components.The exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, histopathology reports, serial x-rays and office reports are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.

Event Description

Revision of a triathlon tibial component was undertaken as it was loose.It was not not thought to be infected.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• 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: 8077782
• MDR Text Key: 127370309
• Report Number: 0002249697-2018-03740
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050318
• UDI-Public: 07613327050318
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 5520-B-300
• Device Lot Number: C6H9S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 54