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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø48 TWO-HOLES
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MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø48 TWO-HOLES Back to Search Results
Catalog Number 01.32.148DH
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 02/12/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018.Lot 170133: (b)(4) items manufactured and released on (b)(6) 2017.Expiration date: 2022-04-11.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 complaining of dislocation 4 months after primary.The surgeon believes there was too much anteversion from the primary surgery.The surgery was completed successfully.
 
Additional Manufacturer Narrative
21.10.2019: it was confirmed that the patient is male.
 
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Brand Name
MPACT ACETABULAR SHELL Ø48 TWO-HOLES
Common Device Name
ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7338232
Report Number3005180920-2018-00138
Device Sequence Number16479492
Product Code LPH
UDI-Device Identifier07630030810732
UDI-Public07630030810732
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K132879
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/28/2019
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 Date04/11/2022
Device Catalogue Number01.32.148DH
Device Lot Number170133
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2018
Supplement Date Received by Manufacturer02/12/2018
Initial Report FDA Received Date03/14/2018
Supplement Report FDA Received Date10/28/2019
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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