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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT 01.26.2848MHC DOUBLE MOBILITY HC LINER 28/DMD; HIP DOUBLE MOBILITY HC LINER

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MEDACTA INTERNATIONAL SA LINER: MPACT 01.26.2848MHC DOUBLE MOBILITY HC LINER 28/DMD; HIP DOUBLE MOBILITY HC LINER Back to Search Results
Model Number 01.26.2848MHC
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/30/2023
Event Type  Injury  
Event Description
The patient came in complaining of a leg length discrepancy and the cause is unknown.At about 1 year and 2 months post primary, the surgeon revised the head and liner.The surgery was completed successfully.
 
Manufacturer Narrative
Batch review performed on 13 june 2023: lot 2116151: (b)(4) items manufactured and released on 12-jan-2022.Expiration date: 2026-12-21.No anomalies found related to the problem.To date, 154 items of the same lot have been sold without any similar reported event in the period of review.Other device involved: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot 2113556: (b)(4) items manufactured and released on 13-dec-2021.Expiration date: 2026-11-23.No anomalies found related to the problem.To date, 131 items of the same lot have been sold without any similar reported event in the period of review.
 
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Brand Name
LINER: MPACT 01.26.2848MHC DOUBLE MOBILITY HC LINER 28/DMD
Type of Device
HIP DOUBLE MOBILITY HC LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ   6874
Manufacturer Contact
marco giannessi
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key17215240
MDR Text Key317987565
Report Number3005180920-2023-00492
Device Sequence Number1
Product Code MEH
UDI-Device Identifier07630030807244
UDI-Public07630030807244
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092265
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/28/2023
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
Device Operator Health Professional
Device Model Number01.26.2848MHC
Device Catalogue Number01.26.2848MHC
Device Lot Number2116151
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/02/2023
Initial Date FDA Received06/28/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/12/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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