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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 2; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 2; CEMENTLESS HIP STEM Back to Search Results
Model Number 01.18.232
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 07/13/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14.July.2021: lot 157637: (b)(4) items manufactured and released on 19-apr-2016.Expiration date: 2021-04-05.No anomalies found related to the problem.To date, all items of the same lot have been sold without other similar reported event since 2017.
 
Event or Problem Description
4 years and 10 months after the primary surgery the patient came in reporting pain due to aseptic loosening of the femoral stem.The surgeon revised the stem, head and liner.
 
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Brand Name
STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 2
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12223902
Report Number3005180920-2021-00641
Device Sequence Number4440639
Product Code LZO
UDI-Device Identifier07630030804571
UDI-Public07630030804571
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121011
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2021
Serviced by Third Party (Y/N)N
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 Date04/05/2021
Device Model Number01.18.232
Device Catalogue Number01.18.232
Device Lot Number157637
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2021
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;
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