MAUDE Adverse Event Report: HIP IMPLANT; PROSTHESIS, HIP

Device Problems Break (1069); Corroded (1131); Material Separation (1562)

Patient Problem Pain (1994)

Event Date 04/24/2019

Event Type  Injury  

Event Description

Upon removal of the hip implant, findings included: "dissociated large metal head from femoral component "metallosis with destruction of the capsule and a large majority of the abductor tendons.Pt reported pain for the last 3 months.Has had implant for approx 13 years.

• Brand Name: HIP IMPLANT
• Type of Device: PROSTHESIS, HIP
• MDR Report Key: 8675484
• MDR Text Key: 147446315
• Report Number: MW5087179
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 65 YR
• Patient Weight: 121