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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 Ø52
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MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52 Back to Search Results
Catalog Number 01.32.152MB
Health Effect - Clinical Code Pain (1994)
Date of Event 12/21/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 january 2019: lot 170994: (b)(4) items manufactured and released on 12-jul-2017.Expiration date: 2022-06-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in, 1 year and 3 months after primary surgery, complaining of pain caused by a loose cup.The surgeon revised the cup, head and liner and the surgery was completed successfully.
 
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Brand Name
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52
Common Device Name
DOUBLE MOBILITY ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8256603
Report Number3005180920-2018-01115
Device Sequence Number16643013
Product Code LPH
UDI-Device Identifier07630030860973
UDI-Public07630030860973
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K143453
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/17/2019
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 Date06/27/2022
Device Catalogue Number01.32.152MB
Device Lot Number170994
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/21/2018
Initial Report FDA Received Date01/17/2019
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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