MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD SHORT NECK 36MM; HIP COMPONENT

Model Number	38AM3604
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to metal on metal complications.Implant was removed.Additional information received on 09/23/2020 from (b)(6): adding product information and updating implant date.Additional information received on 09/25/2020 from (b)(6): confirmation of the product number of the shell.

• Brand Name: CONSERVE A-CLASS BFH HEAD SHORT NECK 36MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10673315
• Report Number: 3010536692-2020-00657
• Device Sequence Number: 19583199
• Product Code: KWA
• UDI-Device Identifier: M68438AM36041
• UDI-Public: M68438AM36041
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 38AM3604
• Device Catalogue Number: 38AM3604
• Device Lot Number: 057437831
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention