MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 50MM; HIP COMPONENT

Model Number	38AM5004
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, plaintiff had a total hip arthroplasty on (b)(6) 2008, on (b)(6) 2009 plaintiff underwent a revision surgery, in this surgery, the conserve plus cup was removed and replaced with a wright medical dynasty cup; the conserve total a-class headcobalt-chromium head was removed and replaced with a conserve a-class head cobalt-chromium head.In addition, the following wright medical hip component devices were implanted during this surgery: acetabular liner (lot no.039828320); acetabular shell (lot no.068632095); and, another component (lot no.059862510).The stem and neck were not indicated as revised components.Product id: pha00268 profemur® z femoral stem s 5 1/3 tp coated cement less, lot: 117488870, qty: 1.Product id: pha01204 profemur® neck neutral long, lot: 107484845, qty: 1.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 50MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 14377487
• Report Number: 3010536692-2022-00190
• Device Sequence Number: 17639754
• Product Code: KWA
• UDI-Device Identifier: M68438AM50041
• UDI-Public: M68438AM50041
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2022

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: 38AM5004
• Device Catalogue Number: 38AM5004
• Device Lot Number: 087466397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/12/2022
• 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