Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 6; CEMENTLESS STEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 6; CEMENTLESS STEM Back to Search Results
Model Number 01.18.146
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 06/22/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 july 2021: lot 114072: (b)(4) items manufactured and released on 16-jan-2012.Expiration date: 2016-12-31.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
Revision surgery about 9 years and 5 months after primary due to stem loosening.The primary surgery exact date is unknown, it was in 2012.Some granuloma from abrasion were found in the hip, the hip system had a metal-on-metal bearing from a competitor.The revision surgery was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STEM: AMISTEM H HA COATED LAT STEM SIZE 6
Common Device Name
CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12223756
Report Number3005180920-2021-00637
Device Sequence Number11872231
Product Code LZO
UDI-Device Identifier07630030804229
UDI-Public07630030804229
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/26/2021
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 Date12/31/2016
Device Model Number01.18.146
Device Catalogue Number01.18.146
Device Lot Number114072
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/12/2021
Initial Report FDA Received Date07/26/2021
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;
Patient Age68 YR
-
-