MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DURACON UNIVERSAL B/P NON-BEADED; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 6632-3-615

Device Problem Loss of Osseointegration (2408)

Patient Problems Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

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.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.H3 other text : device not returned to the manufacturer.

Event Description

It was reported that the patient's right knee was revised due to lysis and loosening of the tibial component.The entire knee construct was revised to convert the knee to a triathlon ts knee.There were no allegations against the revised insert.

• Brand Name: DURACON UNIVERSAL B/P NON-BEADED
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18823373
• MDR Text Key: 336739297
• Report Number: 0002249697-2024-00331
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07613327033250
• UDI-Public: 07613327033250
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915512
• 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: 03/02/2024

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: 10/31/2009
• Device Catalogue Number: 6632-3-615
• Device Lot Number: PSBZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 03/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2004
• 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): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 106 KG