MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® BFH® HEAD 46MM SHORT NECK; HIP COMPONENT

Model Number	38014604
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
Event or Problem Description
Allegedly, the patient has a surgery of right total hip replacement and received a mom right hip system implant.Then the patient suffered infection physical injury, pain, bodily impairment, debiliting lack of mobility, high levels of toxic metal levels, conscious pain and suffering and loss of earnings.Loosening of the acetabular cup.
Additional Manufacturer Narrative
See memo attached.- attachment: [8.Memorandummomwd011615_02_1.Pdf].

• Brand Name: CONSERVE® BFH® HEAD 46MM SHORT NECK
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9182511
• Report Number: 3010536692-2019-01086
• Device Sequence Number: 2830880
• Product Code: KWA
• UDI-Device Identifier: M684380146041
• UDI-Public: M684380146041
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: Other
• Device Model Number: 38014604
• Device Catalogue Number: 38014604
• Device Lot Number: 087460710
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 05/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention