MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD MEDIUM NECK 46MM; HIP COMPONENT

Model Number	38AM4600
Medical Device Problem Codes	Corroded (1131); Material Disintegration (1177)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the patient had pain in her left hip, subject has a history of elevated cobalt and chromium levels.Subject has a total of five total joints in her body, including both hips.The pi ordered metal ion testing from joint fluid from both hips.Not enough fluid was obtained from the right hip to perform testing cobalt and chromium metal ions were present in the left hip fluid.
Event or Problem Description
Allegedly, the patient had pain in her left hip, subject has a history of elevated cobalt and chromium levels.Subject has a total of five total joints in her body, including both hips.The physician ordered metal ion testing from joint fluid from both hips.Not enough fluid was obtained from the right hip to perform testing.Cobalt and chromium metal ions were present in the left hip fluid.Update december 5 2019.The conserve total a-class femoral head was removed.Corrosion of the femoral head-neck/ trunnion junction was noted.The modular neck and femoral stem were well fixed and were not revised.The subject was discharged the same day.
Additional Manufacturer Narrative
Updated lot information, hospital information, event problem and evaluation codes.

• Brand Name: CONSERVE A-CLASS BFH HEAD MEDIUM NECK 46MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9444145
• Report Number: 3010536692-2019-01175
• Device Sequence Number: 11314649
• Product Code: KWA
• UDI-Device Identifier: M68438AM46001
• UDI-Public: M68438AM46001
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 38AM4600
• Device Catalogue Number: 38AM4600
• Device Lot Number: 079891170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 08/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 96