MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. RIM-LOCK METAL LINER COCR; HIP COMPONENT

Model Number PHA04712

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The complaint will be updated once the investigation is completed.Trends will be evaluated.

Event Description

Allegedly, patient was revised due to infection; adverse soft tissue reaction to particle debris (right).Revision njr number: (b)(4).Primary asa: p2 - mild disease not incapacitating.Product not revised and has no complaint stated against the component: profemur® l hip stem size 5 ha coated, pha05510, lot: 38564025; profemur® neck a/r var/val 1 long, pha01224, lot: 48573065; procotyl l beaded and ha coated cup size 56mm, pha06266, lot: 88644639.

• Brand Name: RIM-LOCK METAL LINER COCR
• 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: 8656138
• MDR Text Key: 146576460
• Report Number: 3010536692-2019-00794
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

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
• Device Operator: Other
• Device Model Number: PHA04712
• Device Catalogue Number: PHA04712
• Device Lot Number: 116389410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2019
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 05/08/2020
• 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: 71 YR