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

Model Number PHA012222

Device Problems Break (1069); Noise, Audible (3273)

Patient Problems Keratitis (1944); Pain (1994)

Event Date 01/16/2022

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, on (b)(6) 2022, during a turning movement, patient heard/felt a cracking noise in the area of the right hip since then the patient has not been able to bear any weight, additional pain in the area of the right hip during movements.Allegedly, the neck is broken.

Event Description

Allegedly, on (b)(6) 2022, during a turning movement, patient heard/felt a cracking noise in the area of the right hip since then the patient has not been able to bear any weight, additional pain in the area of the right hip during movements.Allegedly, the neck is broken.Additional information received on (b)(6),2022 via basg "vigilance - request for information" indicating that a device procotyl w pfanne 52 mm,lot: 107476510 was involved in this event however lot number and partid does not match each other.After further discussions with basg and healthcare facility contact , response for attempt #3 and additional information were received on (b)(6) 2022 and (b)(6),2022.The information stated that the device procotyl w pfanne 52 mm actually has the lot: 107472034/partid:pha0-3852.They also confirmed that there's a promefur stem with lot: 107476510/partid:pha00240.Components not revised: partid:pha0-3852, procotyl w pfanne 52 mm, lot: 107472034.Partid:pha00240, profemur® z femoral stem s 5 , lot:107476510.

• 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: 13535404
• MDR Text Key: 285622239
• Report Number: 3010536692-2022-00046
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHA012222
• Device Catalogue Number: PHA012222
• Device Lot Number: W05327785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/26/2022
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male