MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD LONG NECK 44MM; HIP COMPONENT

Model Number	38AM4435
Medical Device Problem Codes	Material Disintegration (1177); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Reaction (2414); Metal Related Pathology (4530)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, information received from attending physician on (b)(6) 2011 a total hip arthroplasty was performed.On (b)(6) 2019 due to adverse reaction to metal debris (armd) suspected hip arthroplasty and a revision was performed on (b)(6) 2019.
Additional Manufacturer Narrative
Report was updated to include manufacturer analysis of the returned products.Updated patient, initial reporter information, event problem and investigation codes.

• Brand Name: CONSERVE A-CLASS BFH HEAD LONG NECK 44MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9933135
• Report Number: 3010536692-2020-00325
• Device Sequence Number: 17081911
• Product Code: KWA
• UDI-Device Identifier: M68438AM44351
• UDI-Public: M68438AM44351
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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: 38AM4435
• Device Catalogue Number: 38AM4435
• Device Lot Number: 069886185
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 01/08/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0689-2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention