LINER: MPACT DOUBLE MOBILITY HC LINER ? 54/28 01.26.2854MHC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-13 for LINER: MPACT DOUBLE MOBILITY HC LINER ? 54/28 01.26.2854MHC manufactured by Medacta International Sa.

Event Text Entries

[175049624] Batch review performed on 20 december 2019. Lot 1903332: (b)(4) items manufactured and released on 24-jul-2019. Expiration date: 2024-07-08. 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. Additional implant involved in the event, batch review performed on 20 december 2019. Ball heads: mectacer 01. 29. 202 biolox delta ceramic ball head 12/14? 28 size m 0 (k112115) lot. 1903847 lot 1903847: (b)(4) items manufactured and released on 26-jul-2019. Expiration date: 2024-07-13. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold with one similar event reported.
Patient Sequence No: 1, Text Type: N, H10


[175049625] The patient came in, one month after primary surgery, due to signs of infection and the pathogen is unknown. The surgeon performed a washout and revised the head and liner. The surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005180920-2019-01141
MDR Report Key9580570
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-01-13
Date of Report2020-01-13
Date of Event2019-12-17
Date Mfgr Received2019-12-17
Device Manufacturer Date2019-07-24
Date Added to Maude2020-01-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR STEFANO BAJ
Manufacturer StreetSTRADA REGINA
Manufacturer CityCASTEL SAN PIETRO, SWITZERLAND 6874
Manufacturer CountrySZ
Manufacturer Postal6874
Manufacturer G1MEDACTA INTERNATIONAL SA
Manufacturer StreetSTRADA REGINA
Manufacturer CityCASTEL SAN PIETRO, 6874
Manufacturer CountrySZ
Manufacturer Postal Code6874
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLINER: MPACT DOUBLE MOBILITY HC LINER ? 54/28
Generic NameDOUBLE MOBILITY HC LINER
Product CodeMEH
Date Received2020-01-13
Catalog Number01.26.2854MHC
Lot Number1903332
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDACTA INTERNATIONAL SA
Manufacturer AddressSTRADA REGINA CASTEL SAN PIETRO, 6874 SZ 6874


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-13

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