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

Model Number	38AM4804
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, patient has a scheduled revision surgery for (b)(6) 2022.Not known revision causes yet.Original surgery invoice found on (b)(6),2022.Additional information received on (b)(6), 2022 from reporter stating: "the surgeon explained to me that she is keeping the cup and stem and will be converting it to a dual mobility head and liner and while in there changing the ti neck to cobalt chrome neck." components that will not be revised: 38ha4854 conserve® plus ha cup 48mm id 54mm od beaded, lot#: 067436643, qty:1 pha00262 profemur® z femoral stem s 2 1/3 tp coated cement less, lot#: 086363061, qty:1.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 48MM
• 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: 13637172
• Report Number: 3010536692-2022-00056
• Device Sequence Number: 11316336
• Product Code: KWA
• UDI-Device Identifier: M68438AM48041
• UDI-Public: M68438AM48041
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2022

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: 38AM4804
• Device Catalogue Number: 38AM4804
• Device Lot Number: 055216748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 03/01/2022
• 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: Unknown