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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 03/05/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
 
Event Description
It was reported the patient was revised to address in-vivo humeral baseplate implant fracture.Attempts have been made and no further information has been provided.
 
Event Description
No additional information received.
 
Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.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.
 
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Brand Name
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7379264
MDR Text Key103777090
Report Number0001825034-2018-02187
Device Sequence Number1
Product Code PAO
Combination Product (y/n)N
PMA/PMN Number
PK080642
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 01/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date02/06/2021
Device Model NumberN/A
Device Catalogue Number115340
Device Lot Number424650
Other Device ID Number00880304475335
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
113632 COMP PRIMARY STEM LOT 317150; 115310 COMP RVRS SHLDR GLNSP LOT 973220; 115330 COMP RVRS LOT 295480; 115383 COMP RVS CNTRL, LOT 504010; 118001 VERSA-DIAL/COMP LOT 925250; 180500 SCREW, LOT 129240; 180500 SCREW, LOT 282700; 180504 SCREW, LOT 525350; 32-486265 1/8 QUICK REL DRL , LOT 548120; 405889 COMP RVS, LOT 621400; 406236 GLENOSPHERE LOT 753570; XL-115363, ARCOM XL, LOT 857250
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
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