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

Model Number	38AM4435
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Reaction (2414); Metal Related Pathology (4530)
Date of Event	01/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, during revision the head and neck have been removed because were damage, seems to be due to armd wear, so the doctor requested the product removed and requested that be examined closely within the range and for the amount of wear and the degree of discoloration.The doctor will not return the cup and stem.
Event or Problem Description
Allegedly, the patient was revised due to a suspected adverse tissue reaction to the implanted products.During revision, the head and neck were removed because of damage that appeared to be implant wear.The physician has requested that the exhibited wear and discoloration of the revised products be analyzed.The acetabular cup and femoral stem will not be returned.Additional information received from (b)(6) on 02/26/2021: hospital and physician information.
Additional Manufacturer Narrative
The "device" involved in this event was returned for evaluation.Updated incident description, initial reporter information, adverse 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: 9758795
• Report Number: 3010536692-2020-00161
• Device Sequence Number: 16845828
• 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: 2008
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: 107492865
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR