MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® BFH® HEAD 48MM MEDIUM NECK; HIP COMPONENT

Model Number 38014800

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

See attached.

Event Description

Allegedly in or around march 2010, there was a ct report which identified a collection around the right hip prosthesis.In november 2012, his right had an mri scan which identified "very large collection over the right greater trochanter.It measures 10cm in the long axis and 4cm in the transverse axis.As the collective approaches the hip it extends over the anterior surface of the greater trochanger towards the anterior capsule.It is understood that the right hip is going to have to be revised.Additional information from njr received on 03/04/2024: allegedly, patient was revised due to unexplained pain | adverse soft tissue reaction to particulate debris.Revision njr number: 1912830.Side: r.Primary asa: p2 - mild disease not incapacitating.

• Brand Name: CONSERVE® BFH® HEAD 48MM MEDIUM NECK
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 19012842
• MDR Text Key: 339030944
• Report Number: 3010536692-2024-00149
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: M684380148001
• UDI-Public: M684380148001
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K021349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2024

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 Model Number: 38014800
• Device Catalogue Number: 38014800
• Device Lot Number: 048571505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male