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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER 32/E; HIP ACETABULAR INSERT
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MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER 32/E; HIP ACETABULAR INSERT Back to Search Results
Model Number 01.32.3244HCT
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 08/20/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 september 2021: lot 140550: (b)(4) items manufactured and released on 22-oct-2014.Expiration date: 2019-aug-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 since 2017.
 
Event or Problem Description
The patient came in reporting instability and the cause of instability is unknown.5 years and 1 month after primary the surgeon revised the mpact flat liner hc 32/e with a flat pe hc liner ø36/e.The surgery was completed successfully.
 
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Brand Name
LINER: MPACT FLAT PE HC LINER 32/E
Common Device Name
HIP ACETABULAR INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12467904
Report Number3005180920-2021-00752
Device Sequence Number4815281
Product Code LPH
UDI-Device Identifier07630030811913
UDI-Public07630030811913
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K103721
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) 09/14/2021
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 Date08/31/2019
Device Model Number01.32.3244HCT
Device Catalogue Number01.32.3244HCT
Device Lot Number140550
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/20/2021
Initial Report FDA Received Date09/14/2021
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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