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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø32/E; FLAT PE LINER
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MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø32/E; FLAT PE LINER Back to Search Results
Catalog Number 01.32.3244HCT
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/17/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 august 2017.Lot 167596: (b)(4) items manufactured and released on 16 february 2017.Expiration date: 2022-01-31.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 due to signs of infection.The pathogen is not available.The surgeon washed out the hip and left all components in place.The surgery was completed successfully.X-rays and explants are not available.
 
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Brand Name
MPACT FLAT PE HC LINER Ø32/E
Common Device Name
FLAT PE LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key6797198
Report Number3005180920-2017-00445
Device Sequence Number16357488
Product Code LPH
UDI-Device Identifier07630030811913
UDI-Public07630030811913
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K103721
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/16/2017
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 Date01/31/2022
Device Catalogue Number01.32.3244HCT
Device Lot Number167596
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/17/2017
Initial Report FDA Received Date08/16/2017
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 Age61 YR
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