MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. BIPOLAR HIP ASSEMBLY; HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS

Model Number 1035-42-000

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Hip Fracture (2349)

Event Date 08/16/2020

Event Type  Injury  

Event Description

Pt suffered a subcapital fracture of her right hip.Bipolar hip placed on (b)(6) 2020.The bipolar hip assembly failed and was removed on (b)(6) 2020.It was replaced with another device.The second device failed and was replaced on (b)(6) 2020.

• Brand Name: BIPOLAR HIP ASSEMBLY
• Type of Device: HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 10690095
• MDR Text Key: 211902149
• Report Number: MW5097267
• Device Sequence Number: 1
• Product Code: KWY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/13/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 1035-42-000
• Device Catalogue Number: 103542000
• Device Lot Number: HP7295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 78