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 04/10/2012

Event Type  Injury  

Manufacturer Narrative

Review of the product history records indicates products were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to: "history of left total knee arthroplasty 18 months ago.Chronic pain about the proximal left tibia with concern for aseptic loosening of the tibial component.Grossly loose tibial component.Proc revision lt total knee, tibial component only".

Manufacturer Narrative

Correction of the reported device.Review of the product history records indicates products were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to: "1.History of left total knee arthroplasty 18 months ago.2.Chronic pain about the proximal left tibia with concern for aseptic loosening of the tibial component.3.Grossly loose tibial component.4.Proc revision lt total knee, tibial component only".

• 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: 8504159
• MDR Text Key: 141605235
• Report Number: 0002249697-2019-01582
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327014754
• UDI-Public: 07613327014754
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 5520-B-300
• Device Lot Number: BJJH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR