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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 Ø50; HIP ACETABULAR SHELL
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MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50; HIP ACETABULAR SHELL Back to Search Results
Catalog Number 01.32.150MB
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 10/07/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 october 2019: lot 188879: 44 items manufactured and released on 06-mar-2019.Expiration date: 2024-02-26.No anomalies found related to the problem.To date, 38 items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in complaining of pain due to a cup that had not ingrown properly.The surgeon revised the acetabular shell and the liner with competitor products, almost 3 months after primary.The surgery was completed successfully.
 
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Brand Name
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50
Common Device Name
HIP ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9283645
Report Number3005180920-2019-00932
Device Sequence Number19364529
Product Code LPH
UDI-Device Identifier07630030860966
UDI-Public07630030860966
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K143453
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/05/2019
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 Date02/26/2024
Device Catalogue Number01.32.150MB
Device Lot Number188879
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/07/2019
Initial Report FDA Received Date11/06/2019
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;
Patient Age63 YR
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