MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME; HIP COMPONENT

Model Number PHAC1222

Device Problem Corroded (1131)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to corrosion at the neck-stem junction.Right hip components not revised: dynasty® pc shell 54mm group e dspcge54 1400657.Dynasty® a-class® 38mm 15dg group e crosslinked po product number: dlxple38 lot batch: 0201067755.Conserve® total medium neck sleeve product number: 38ns0000, lot batch: 0711384693.Cancellous self-tapping 6.5mm bone screw 4.0cm len product number: 18080305, lot batch: 0501143695.Cancellous self-tapping 6.5mm bone screw 3.0cm len product number: 18080303, lot batch: 075239810.Legal file received on 11/11/2020 from debby daurer: no additional information was provided.

• Brand Name: PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME
• Type of Device: 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: 10860306
• MDR Text Key: 216853494
• Report Number: 3010536692-2020-00699
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12221
• UDI-Public: M684PHAC12221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHAC1222
• Device Catalogue Number: PHAC1222
• Device Lot Number: 1001229751
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/29/2020
• Date Manufacturer Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention