MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE FEMORAL RESURFACING HEAD 50MM; HIP COMPONENT

Model Number	38031050
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to other| adverse soft tissue reaction to particulate debris.Revision njr number: (b)(4).Side: l.Primary asa: p2: mild disease not incapacitating.

• Brand Name: CONSERVE FEMORAL RESURFACING HEAD 50MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 12315297
• Report Number: 3010536692-2021-00440
• Device Sequence Number: 4448523
• Product Code: KXA
• UDI-Device Identifier: M684380310501
• UDI-Public: M684380310501
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: Health Professional
• Device Model Number: 38031050
• Device Catalogue Number: 38031050
• Device Lot Number: 58547909
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention