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

Model Number	38AM4800
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, possible infection/mom.Patient had what appeared to be a sore or wound on their hip pre surgery, cultures were taken and the head was pulled and a new 28mm long ceramic was used with a stryker dual mobility.The patient has undergone previous revisions due to dislocation, infection on (b)(6) 2010, (b)(6) 2010 and (b)(6) 2010 (all components revised).Right hip.
Additional Manufacturer Narrative
Updated device implant date and event problem codes.The patient index surgery was performed on 2006.The component reported here was implanted on 2010 after a revision surgery.

• Brand Name: CONSERVE A-CLASS BFH HEAD MEDIUM NECK 48MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9491715
• Report Number: 3010536692-2019-01200
• Device Sequence Number: 16201894
• Product Code: KWA
• UDI-Device Identifier: M68438AM48001
• UDI-Public: M68438AM48001
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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: 38AM4800
• Device Catalogue Number: 38AM4800
• Device Lot Number: 049848941
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/22/2019
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 08/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention