REPOSITIONING TOP, 36 N/A 78.00.38-36

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for REPOSITIONING TOP, 36 N/A 78.00.38-36 manufactured by Zimmer Gmbh.

Event Text Entries

[125616036] Unique identifier (udi) # n/a. As no lot number was provided, the device history records could not be reviewed. The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. Additional information has been requested and is currently not available. The implantation and explantation dates are left empty as the device involved in this complaint is an instrument. Hence, no expiration date is captured, for the same reason. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available, an updated report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[125616037] It was reported that black tip is chipped.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0009613350-2018-01109
MDR Report Key8018272
Date Received2018-10-30
Date of Report2019-02-21
Date of Event2018-10-01
Date Mfgr Received2019-02-21
Device Manufacturer Date2015-01-23
Date Added to Maude2018-10-30
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. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER GMBH
Manufacturer StreetSULZER ALLEE 8 SULZER INDUSTRIE PARK
Manufacturer CityWINTERTHUR 8404
Manufacturer CountrySZ
Manufacturer Postal Code8404
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report0

Device Details

Brand NameREPOSITIONING TOP, 36
Generic NameN/A
Product CodeHTR
Date Received2018-10-30
Returned To Mfg2018-10-31
Model NumberN/A
Catalog Number78.00.38-36
Lot Number14.115446
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZIMMER GMBH
Manufacturer AddressSULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-30

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