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

Model Number	38AM4835
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly the patient is experiencing mom complications (left).Additional information received on 05/22/2024 by legal department: allegedly, on (b)(6) 2007 plaintiff had an artificial hip implanted in his left hip in what is known a total hip artoplasty or "tha".He was implanted at cedars-sini medical center.On (b)(6) 2014, plaintiff had a revision of his left hip to convert the bearing surface from mom bearing surface to a metal-on-poly bearing.The surgery was performed at (b)(6) the femoral head was removed.However, the modular neck was well fixed in the femoral stem, and femoral stem was also well fixed, so they were left in place.Products implanted in first revision surgery: zimmer ctm acetabular component 58mm od, 36mmid polyethylene liner wright 36mm femoral head, +7.Mpo non revised products: product id: pha00242, profemur® z femoral stem s 6 cement less, lot: 096375746, qty: (b)(4).Product id: pha01212, profemur® neck a/r var/val 2 short, lot: 106380691, qty: (b)(4).
Additional Manufacturer Narrative
See attached.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD LONG NECK 48MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 19518900
• Report Number: 3010536692-2024-00339
• Device Sequence Number: 6171043
• Product Code: KWA
• UDI-Device Identifier: M68438AM48351
• UDI-Public: M68438AM48351
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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: 38AM4835
• Device Catalogue Number: 38AM4835
• Device Lot Number: 116390097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male