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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES; HIP ACETABULAR SHELL
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MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES; HIP ACETABULAR SHELL Back to Search Results
Catalog Number 01.38.054DH
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 06/19/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 july 2019: lot 1810871: (b)(4) items manufactured and released on 17-jan-2019.Expiration date: 2024-01-06.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
7 days after primary the surgeon revised the patient hip for a loose shell.Cup, liner and screw revised successfully.
 
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Brand Name
CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
Common Device Name
HIP ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8789417
Report Number3005180920-2019-00584
Device Sequence Number19413521
Product Code LPH
UDI-Device Identifier07630030812606
UDI-Public07630030812606
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K171966
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/15/2019
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 Date01/06/2024
Device Catalogue Number01.38.054DH
Device Lot Number1810871
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/19/2019
Initial Report FDA Received Date07/15/2019
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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