MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK A/R 15DG SHORT COBALT CHROME; HIP COMPONENT

Model Number PHAC1242

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Metal Related Pathology (4530); Insufficient Information (4580)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to unknown reasons.

Manufacturer Narrative

Updated: patient's information, additional description, new incidents codes and new investigation codes were added/changed.

Event Description

Allegedly, patient was revised due to unknown reasons.Additional information received on 03/21/2023: allegedly, on or about on (b)(6) 2021, plaintiff reported for a revision/replacement if the femoral head and neck.Dr recommended the revision surgery after plaintiff presented with pain and weakness, adverse local tissue reaction and elevated cobalt levels.Neck (pha01242) and head (pha04426) were implanted during the revision surgery.Products not revised: product id: lot number: qty: 20070031 1830209 1.Dspcgf56 1822203 1.Pha00248 01112839031803042 1.Dlxplf40 15418741813633 1.18080304 177194 1.18080303 1802295 1.

• Brand Name: PROFEMUR® NECK A/R 15DG 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: 12919783
• MDR Text Key: 281656513
• Report Number: 3010536692-2021-00576
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12421
• UDI-Public: M684PHAC12421
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHAC1242
• Device Catalogue Number: PHAC1242
• Device Lot Number: 1787137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/10/2021
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female