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

Model Number PHA01202

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/16/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient had a profemur tlbha (right) on (b)(6)2022 in (b)(6) hospital to remove the head neck due to dislocation and suspected infection.When checking the x-rays before the revision surgery on (b)(6)2022, it was confirmed that the neck was clearly detached from the stem.Dr.(b)(6), the primary surgeon, and dr.(b)(6), the supervising physician, confirmed cases of neck dislodgement.The neck head was removed and checked for damage.The neck pocket was wiped with gauze to preserve the stem inside the body, and the remains were checked visually.No damage was found on either the stem or the neck.The stem was left intact and the wound was closed.Neck, head and bipolar cup were revised.Components not revised: part id: prtl0028, profemur tl stem size 8, lot:1869467 japan-oc-00000270.

• 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: 14105168
• MDR Text Key: 289224675
• Report Number: 3010536692-2022-00120
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

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: PHA01202
• Device Catalogue Number: PHA01202
• Device Lot Number: 1890150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/22/2022
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 03/22/2022
• Supplement Dates FDA Received: 06/16/2022
• 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: 72 YR
• Patient Sex: Male