MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT

Model Number PHA01252

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to pain without loosening components not revised: cotyle "anca" avec trous a/revet.Hap 50, ppr67250, lot v0288744.Tige "anca fit?" rev.Hap 1/3 proximal 14d, ppr67616, lot v04185939.Insert ceram "anca fit?" 28/40 50-52-54/28 al2.O3 bio.Forte, ppr67510, lot u10129286.

• Brand Name: PROFEMUR MODULAR FEMORAL NECK
• 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: 10460349
• MDR Text Key: 210464255
• Report Number: 3010536692-2020-00590
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012521
• UDI-Public: M684PHA012521
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHA01252
• Device Catalogue Number: PHA01252
• Device Lot Number: V06201722
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2019
• 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: 69 YR