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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 48
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MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 48 Back to Search Results
Model Number 01.32.148MB
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 09/28/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 october 2020: lot 185433: (b)(4) items manufactured and released on 05-dec-2018.Expiration date: 2023-11-25.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
Revision surgery 1 year and 5 months after primary for cup loosening.The cause of the loose cup is unknown.The surgeon revised the cup and liner with competitor devices.The surgery was completed successfully.
 
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Brand Name
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 48
Common Device Name
DOUBLE MOBILITY ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10748197
Report Number3005180920-2020-00742
Device Sequence Number3180306
Product Code LPH
UDI-Device Identifier07630030860959
UDI-Public07630030860959
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K143453
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/28/2020
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 Date11/25/2023
Device Model Number01.32.148MB
Device Catalogue Number01.32.148MB
Device Lot Number185433
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/28/2020
Initial Report FDA Received Date10/28/2020
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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