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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT OFFSET 4MM PE HC LINER 36/D; OFFSET PE HC LINER
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MEDACTA INTERNATIONAL SA LINER: MPACT OFFSET 4MM PE HC LINER 36/D; OFFSET PE HC LINER Back to Search Results
Model Number 01.32.3641HC4
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 10/08/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 october 2020: lot 1810834: 120 items manufactured and released on 04-mar-2019.Expiration date: 2024-02-20.No anomalies found related to the problem.To date, 33 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in reporting pain due to a dislocation of the head from the liner 8 months after the primary surgery.The cause of the dislocation is unknown.The surgeon converted the mpact cup to a dual mobility cup, and revised the liner.The surgery was completed successfully.The ball head is a competitor product.The surgeon used posterior-lateral approach during the primary surgery.
 
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Brand Name
LINER: MPACT OFFSET 4MM PE HC LINER 36/D
Common Device Name
OFFSET PE HC LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10778505
Report Number3005180920-2020-00782
Device Sequence Number11705513
Product Code LPH
UDI-Device Identifier07630040731010
UDI-Public07630040731010
Combination Product (Y/N)Y
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K183582
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/03/2020
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 Health Professional
Device Expiration Date02/20/2024
Device Model Number01.32.3641HC4
Device Catalogue Number01.32.3641HC4
Device Lot Number1810834
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/08/2020
Initial Report FDA Received Date11/03/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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