MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R 8DG LONG COBALT CHROME; HIP COMPONENT

Model Number PHAC1234

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to aseptic loosening stem and adverse soft tissue reaction to particle debris.Revision njr number: 4458878.Side:l.Primary asa: p1 - fit and healthy.Components not revised: procotyl l beaded and ha coated cup size 50mm, product id: pha06260, lot id: 1521597.Rim-lock biolox delta ceramic liner 32mm id group d, product id: pha04508, lot id: 1549402.

• Brand Name: PROFEMUR NECK A/R 8DG LONG 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: 10335406
• MDR Text Key: 202738969
• Report Number: 3010536692-2020-00501
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12341
• UDI-Public: M684PHAC12341
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K091423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHAC1234
• Device Catalogue Number: PHAC1234
• Device Lot Number: 1564800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2020
• 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