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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES
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MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES Back to Search Results
Model Number 01.32.150DH
Health Effect - Clinical Code Pain (1994)
Date of Event 02/19/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 march 2021: lot 1811187: (b)(4) items manufactured and released on 10-apr-2019.Expiration date: 2024-04-01.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 reporting groin pain.Post-op x-rays revealed lucency around the acetabular shell.1 year and 7 months after primary the surgeon revised the cup, liner, and head.The surgery was completed successfully.
 
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Brand Name
CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES
Common Device Name
ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11506820
Report Number3005180920-2021-00222
Device Sequence Number14164046
Product Code LPH
UDI-Device Identifier07630030810763
UDI-Public07630030810763
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 Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/17/2021
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 Date04/01/2024
Device Model Number01.32.150DH
Device Catalogue Number01.32.150DH
Device Lot Number1811187
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/19/2021
Initial Report FDA Received Date03/17/2021
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 Age80 YR
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