MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. LINEAGE® ACETABULAR SHELL 56MM QUAD HEMI FLARE STD; HIP COMPONENT

Model Number	36430056
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, when starting with the acetabular time and after performing the respective cleaning and depth to the acetabulum, the final 56 mm microport non-cemented cup is positioned, impacted, verified and a second impaction is performed.After that, the specialist positions the drill for the placement of the screws, positions the first of them and the damage and deformation of the cup is evidenced.From this, the cup 56 is extracted and the anterior cup 54mm is opened and positioned.Surgery was delayed more than 30 minutes.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
Section d.9: date returned has been updated/ section h.6 the investigation has been updated.

• Brand Name: LINEAGE® ACETABULAR SHELL 56MM QUAD HEMI FLARE STD
• 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: 15744552
• Report Number: 3010536692-2022-00411
• Device Sequence Number: 20172119
• Product Code: LPH
• UDI-Device Identifier: M684364300561
• UDI-Public: M684364300561
• 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: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 04/24/2023

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: 36430056
• Device Catalogue Number: 36430056
• Device Lot Number: 154411231908275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 10/25/2022; 10/25/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/29/2022; 04/24/2023
• 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: 66 YR
• Patient Sex: Male