MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520B500

Device Problem Migration (4003)

Patient Problem Injury (2348)

Event Date 02/05/2019

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 was no other similar events for the reported lot.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

It was reported that the patient's right knee was revised due to lateral subsidence of the tibial baseplate.Intra-operatively, the tibial component was noted to be loose.The baseplate and 5x11 insert were revised to a size 5 universal baseplate with a 15x100 cemented stem, two augments, and a 5x13 cs insert.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #5
• 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: anna ryan ; raheen business park; limerick NA ; 61498200
• MDR Report Key: 8390140
• MDR Text Key: 137812594
• Report Number: 0002249697-2019-01249
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041057
• UDI-Public: 07613327041057
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2019

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: 08/31/2023
• Device Catalogue Number: 5520B500
• Device Lot Number: EJT2L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 102