UNKNOWN REGENEREX POST N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-14 for UNKNOWN REGENEREX POST N/A manufactured by Zimmer Biomet, Inc..

Event Text Entries

[108226309] (b)(4). Journal article reference: nelson, clay g. ; brolin, tyler j. ; ford, marcus c. ; smith, richard a. ; azar, frederick m. ; throckmorton, thomas w. (2018). Five-year minimum clinical and radiographic outcomes of total shoulder arthroplasty using a hybrid glenoid component with a central porous titanium post. Journal of shoulder and elbow surgery, 1058-2746/$, pages 1-6. Https://doi. Org/10. 1016/j. Jse. 2018. 01. 012. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03357. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[108226310] It was reported in a journal article that one patient underwent a revision of a total shoulder arthroplasty approximately two (2) years post-implantation due to glenoid component failure. The polyethylene component sheared off the post at the base of the screw-in mechanism which prevented the removal of the titanium post through conventional means. After final removal there was large central defect which limited the ability to implant a new component. Medical repair was done with bone graft and patient was converted to a hemiarthroplasty. No further information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001825034-2018-03358
MDR Report Key7512794
Date Received2018-05-14
Date of Report2018-05-14
Date Mfgr Received2018-04-19
Date Added to Maude2018-05-14
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 BIOMET, INC.
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNKNOWN REGENEREX POST
Generic NamePROTHESIS, SHOULDER
Product CodeMJT
Date Received2018-05-14
Model NumberN/A
Catalog NumberNI
Lot NumberNI
ID NumberNI
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET, INC.
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2018-05-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.