MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. LINEAGE® DURAMER® ACETABULAR LINER 28MM 15° STD GR; HIP COMPONENT

Model Number	36452801
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, at the moment of impacting the insert inside the acetabular cup, it did not remain fixed, it was tried three times.The support was indicated to put the insert in saline solution, in some cases the polyethylene can expand due to heat and soaking it in saline solution is a good tip.The insert was impacted again and it was stable, then the hip was reduced and at that moment the doctor observed that the insert moved out of position, he moved it with his fingers and finished the procedure.The doctor states that he was left with many doubts and says that there is a risk of dislocation since it was not stable.So far the patient is well and has not presented any inconvenience, we continue to follow up.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: LINEAGE® DURAMER® ACETABULAR LINER 28MM 15° STD GR
• Common Device Name: 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: 13370584
• Report Number: 3010536692-2022-00011
• Device Sequence Number: 19353870
• Product Code: LPH
• UDI-Device Identifier: M684364528011
• UDI-Public: M684364528011
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K002149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2022

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
• Operator of Device: Other
• Device Model Number: 36452801
• Device Catalogue Number: 36452801
• Device Lot Number: 1878179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 03/20/2022
• 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 Sex: Female