ARPE HEAD CURVE LONG +2 N/A P0203AL4

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-01-22 for ARPE HEAD CURVE LONG +2 N/A P0203AL4 manufactured by Biomet France S.a.r.l..

Event Text Entries

[133709013] (b)(4). Report source, foreign - event occurred in (b)(6). The device was not returned to the manufacturer. Therefore it could not be analyzed the device manufacturing quality record indicates that the released product met all requirements to perform as intended. No root cause could be determined, however this is an expected risk that the implant can be damaged in case of fall of the patient if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10


[133709014] It was reported that patient underwent revision surgery due to dislocation after a fall. The implant head was removed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006946279-2019-00059
MDR Report Key8266227
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-01-22
Date of Report2019-01-21
Date of Event2018-07-24
Date Mfgr Received2018-07-24
Device Manufacturer Date2017-10-31
Date Added to Maude2019-01-22
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 ContactMS. H BATAILLE
Manufacturer StreetPLATEAU DE LAUTAGNE BP75
Manufacturer CityVALENCE 26903
Manufacturer CountryFR
Manufacturer Postal26903
Manufacturer Phone0334757591
Manufacturer G1BIOMET FRANCE S.A.R.L.
Manufacturer StreetPLATEAU DE LAUTAGNE BP75
Manufacturer CityVALENCE CEDEX 26903
Manufacturer CountryFR
Manufacturer Postal Code26903
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameARPE HEAD CURVE LONG +2
Generic NameMETACARPAL PROSTHESIS
Product CodeKWG
Date Received2019-01-22
Model NumberN/A
Catalog NumberP0203AL4
Lot Number0001267935
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET FRANCE S.A.R.L.
Manufacturer AddressPLATEAU DE LAUTAGNE BP75 VALENCE CEDEX 26903 FR 26903


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-01-22

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