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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING LAT STEM SIZE 4; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING LAT STEM SIZE 4; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.18.184
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 09/18/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 october 2018.Lot 163715: (b)(4) items manufactured and released on 26 july 2016.Expiration date: 2021-07-04.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 performed due to stem loosening one year and 8 months after primary surgery.
 
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Brand Name
AMISTEM-H PROXIMAL COATING LAT STEM SIZE 4
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7968809
Report Number3005180920-2018-00795
Device Sequence Number19204470
Product Code LZO
UDI-Device Identifier07630030804496
UDI-Public07630030804496
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K161635
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/16/2018
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 Date07/04/2021
Device Catalogue Number01.18.184
Device Lot Number163715
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/18/2018
Initial Report FDA Received Date10/16/2018
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;
Patient Age55 YR
Patient Weight108
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