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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL DIAMETER 52 TWO-HOLES; ACETABULAR CUP
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MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL DIAMETER 52 TWO-HOLES; ACETABULAR CUP Back to Search Results
Model Number 01.32.152DH
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 07/13/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 july 2021: lot 1910257: (b)(4) items manufactured and released on 16-march-2020.Expiration date: 2025-march-04.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
The patient came in reporting pain due to cup instability and the cause of the cup instability is unknown.6 months after primary the surgeon revised the cup, head, and liner and the surgery was completed successfully.No cup loosening detected.
 
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Brand Name
CUP: MPACT ACETABULAR SHELL DIAMETER 52 TWO-HOLES
Common Device Name
ACETABULAR CUP
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12238522
Report Number3005180920-2021-00640
Device Sequence Number2871089
Product Code LPH
UDI-Device Identifier07630030810794
UDI-Public07630030810794
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 Year2021
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) 07/28/2021
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 Date03/04/2025
Device Model Number01.32.152DH
Device Catalogue NumberLPH01.32.152DH
Device Lot Number1910257
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2021
Initial Report FDA Received Date07/28/2021
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;
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