MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. POLY 0DG LINER 36MM GRP D A-CLASS® IMPLANT PARTNER; HIP COMPONENT

Model Number	DLXPGD36WD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, disassociation of poly liner from shell.Revision procedure entailed removing the femoral head and disassociated poly liner.The shell was well affixed so the dr.Proceeded with inserting a dual mobility metal liner with the appropriately sized liner, dual mobility insert, and appropriate ceramic 28mm head non-revised products: product id: dbfpgd52 dynasty® bf shell primary 52mm group d/ lot no.: 1955983/ qty: 1 product id: prglcls1 profemur® gladiator® classic plasma size 1 straight neck/ lot no.: 1936519/ qty: 1.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: POLY 0DG LINER 36MM GRP D A-CLASS® IMPLANT PARTNER
• 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: 20313870
• Report Number: 3010536692-2024-00448
• Device Sequence Number: 8005133
• Product Code: LZO
• UDI-Device Identifier: M684DLXPGD36WD1
• UDI-Public: M684DLXPGD36WD1
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K140043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: DLXPGD36WD
• Device Catalogue Number: DLXPGD36WD
• Device Lot Number: 1909826
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 92 KG