UNKNOWN FINGER IMPLANT UNK FINGER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-22 for UNKNOWN FINGER IMPLANT UNK FINGER manufactured by Depuy Orthopaedics, Inc. 1818910.

Event Text Entries

[103408991] If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[103408992] Patient initiated complaint received. Received a voicemail from patient informing about the broken implants of her right hand. She said the middle finger on her right hand is slightly off while the ring finger is completely off this was implanted on (b)(6) 2012. Unable to provide the part and lot number of the products implanted. Currently the patient is wearing splints, she already have 3 splints and waiting for the last one. Patient said, she already spent (b)(6) of the splints alone. Her surgeon wasn't sure on what to do about her case. Apologized and empathized to patient. Explained to her about the authorization letter, this will be sent through mail. There is no revision reported at this time. Doi: (b)(6) 2012 : dor: not revised (right hand). Patient is bilateral, please see (b)(4) (left hand).
Patient Sequence No: 1, Text Type: D, B5


[112493742] Product complaint # ==> pc-(b)(4). Investigation summary ==> no device associated with this report was received for examination. The investigation could not draw any conclusions regarding the reported event. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1818910-2018-55886
MDR Report Key7362026
Date Received2018-03-22
Date of Report2018-03-01
Date Mfgr Received2018-03-23
Date Added to Maude2018-03-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMR. CHAD GIBSON
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465820988
Manufacturer CountryUS
Manufacturer Postal465820988
Manufacturer Phone5743725905
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNKNOWN FINGER IMPLANT
Generic NameFINGER IMPLANT
Product CodeKYJ
Date Received2018-03-22
Catalog NumberUNK FINGER
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-22

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