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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 50 NO-HOLE
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MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 50 NO-HOLE Back to Search Results
Model Number 01.32.150SH
Medical Device Problem Code Malposition of Device (2616)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/21/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 june 2021: lot 2000212: (b)(4) items manufactured and released on 29-apr-2020.Expiration date: 2025-04-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
Revision surgery 1 year after primary because the cup was too cranial and medialized.Cup, head and liner revised successfully.
 
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Brand Name
CUP: MPACT ACETABULAR SHELL 50 NO-HOLE
Common Device Name
ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12157188
Report Number3005180920-2021-00576
Device Sequence Number4616379
Product Code LPH
UDI-Device Identifier07630030810787
UDI-Public07630030810787
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K132879
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 07/13/2021
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 Date04/20/2025
Device Model Number01.32.150SH
Device Catalogue Number01.32.150SH
Device Lot Number2000212
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/21/2021
Initial Report FDA Received Date07/13/2021
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 Age87 YR
Patient Weight73
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