MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD LONG NECK 54MM; HIP COMPONENT

Model Number	38AM5435
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, mom.Head was pulled and stryker dual mobility liner was used with our metal +7mm 28mm head (left hip).The cup was not revised but captured as a complaint due to mom allegations.Other items not revised: profemur raz stem pyrd0008 lot 036284376.Profemur modular neck pha01252 lot 076363593.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD LONG NECK 54MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9331079
• Report Number: 3010536692-2019-01134
• Device Sequence Number: 2243832
• Product Code: LZO
• UDI-Device Identifier: M68438AM54351
• UDI-Public: M68438AM54351
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2019

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: 38AM5435
• Device Catalogue Number: 38AM5435
• Device Lot Number: 085257625
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR