MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. LINEAGE ACETABULAR SHELL 56MM SOLID HEMI FLARE ST; HIP COMPONENT

Model Number	36450056
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Unequal Limb Length (4534)
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, the patient was revised due to leg length discrepancy of about 4mm on the right side.Radiographic images showed possible loosening of cup and stem.The revision was scheduled to replace the head and neck and possibly the liner.When trying to remove the neck from the stem, it could not be separated.So the stem was also removed.Additional information received on 02/02/2021: revised part and lot numbers were provided as well as the reason for revision, moreover the revision surgery date.

• Brand Name: LINEAGE ACETABULAR SHELL 56MM SOLID HEMI FLARE ST
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11358022
• Report Number: 3010536692-2021-00099
• Device Sequence Number: 13632119
• Product Code: LPH
• UDI-Device Identifier: M684364500561
• UDI-Public: M684364500561
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K002149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• 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): 04/21/2021

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: 36450056
• Device Catalogue Number: 36450056
• Device Lot Number: 019774838
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/02/2021
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 04/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention