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

Model Number	38014800
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
See attached.
Event or Problem 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
• Common Device Name: 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
• Report Number: 3010536692-2024-00149
• Device Sequence Number: 7993760
• Product Code: KWA
• UDI-Device Identifier: M684380148001
• UDI-Public: M684380148001
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male