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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø28/B; FLAT PE LINER
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MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø28/B; FLAT PE LINER Back to Search Results
Catalog Number 01.32.2837HCT
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 12/18/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 january 2018 lot 165672: (b)(4) items manufactured and released on 05 october 2016.Expiration date: 2021-09-20 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.Biolox delta ceramic ball head 12/14 ø 28 size l +3.5 01.29.203 (k112115) lot.168599: (b)(4) items manufactured and released on 05 april 207.Expiration date: 2022-03-26 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
Revision surgery due to dislocation.No trauma reported.
 
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Brand Name
MPACT FLAT PE HC LINER Ø28/B
Common Device Name
FLAT PE LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7199212
Report Number3005180920-2017-00842
Device Sequence Number19061911
Product Code LPH
UDI-Device Identifier07630030811531
UDI-Public07630030811531
Combination Product (Y/N)N
Initial Reporter CountryJA
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 company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/17/2018
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 Date09/20/2021
Device Catalogue Number01.32.2837HCT
Device Lot Number165672
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/18/2017
Initial Report FDA Received Date01/17/2018
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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