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

Model Number PHAC1222

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Fluid Discharge (2686)

Event Type  Injury  

Event Description

Allegedly, patient's wound is still draining and groin pain in his right hip.Head, neck, liner and dual mobility were swapped out for a new ones.Previous revision captured under the incident group: (b)(4).

• 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: 10339519
• MDR Text Key: 205525851
• Report Number: 3010536692-2020-00520
• 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: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• 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: 1790967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/06/2020
• Date Manufacturer Received: 07/06/2020
• 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
• Patient Age: 70 YR