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

Model Number	PHA01254
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, unable to remove the neck, the entire stem was removed.Reporting party's findings and response status: there may have been impurities in the neck-stem joint, or the stem may have stuck due to cold flow.Additional information received on 2023-11-09: during neck removal, the stem came out unintentionally (is it possible that the fixation of the stem to the bone was insufficient).Additional information received on 2023-11-13: the primary reason for revision involved loosening of a non-mpo cemented cup.During this surgery, the plan was to revise the neck and head unless infection/loosening of the stem was also found.No infection was found, and only the neck was to be removed.However, the surgical team could not remove the neck from the stem which resulted in full revision of the femoral stem as well.Japan (b)(4).
Event or Problem Description
Allegedly, unable to remove the neck, the entire stem was removed.Reporting party's findings and response status: there may have been impurities in the neck-stem joint, or the stem may have stuck due to cold flow.Additional information received on 2023-11-09: during neck removal, the stem came out unintentionally (is it possible that the fixation of the stem to the bone was insufficient).Additional information received on 2023-11-13: the primary reason for revision involved loosening of a non-mpo cemented cup.During this surgery, the plan was to revise the neck and head unless infection/loosening of the stem was also found.No infection was found, and only the neck was to be removed.However, the surgical team could not remove the neck from the stem which resulted in full revision of the femoral stem as well.(b)(4).

• Brand Name: PROFEMUR® MODULAR FEMORAL NECK
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 18216289
• Report Number: 3010536692-2023-00219
• Device Sequence Number: 5671406
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012541
• UDI-Public: M684PHA012541
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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
• Operator of Device: Other
• Device Model Number: PHA01254
• Device Catalogue Number: PHA01254
• Device Lot Number: 1492428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female