MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR FEMORAL HEAD 28MM SLT TAPER +0MM NECK; HIP COMPONENT

Model Number	26012802
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to pain.Revision njr number: (b)(4) side: r.Primary asa: p2 - mild disease not incapacitating components not revised: profemur® l hip stem size 3 ha coated product id pha05506 lot id 511348822.Profemur® neck 8dg a/r short product id pha01232 lot id 511357101.

• Brand Name: COCR FEMORAL HEAD 28MM SLT TAPER +0MM NECK
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10337626
• Report Number: 3010536692-2020-00506
• Device Sequence Number: 3178374
• Product Code: LPH
• UDI-Device Identifier: M684260128021
• UDI-Public: M684260128021
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K932222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: Health Professional
• Device Model Number: 26012802
• Device Catalogue Number: 26012802
• Device Lot Number: 611359745
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 07/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention