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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK DISTAL HUMERAL COMPONENT; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. UNK DISTAL HUMERAL COMPONENT; PROSTHESIS, SHOULDER Back to Search Results
Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Joint Dislocation (2374); Peripheral Nervous Injury (4414)
Event Type  Injury  
Event Description
It was reported in a surgeon survey involving the comprehensive segmental revision system that an unknown number of patients experienced complications including dislocation, instability, infection, and nerve irritation/palsy post implantation.No further details were provided concerning the number of complications or correlation to a surgical case.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4).D10: unk humeral head cat#ni lot#ni.Unk proximal humeral component cat#ni lot#ni.Unk intercalary segment cat#ni lot#ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02585; 0001825034 - 2023 - 02586; 0001825034 - 2023 - 02588.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.The entirety of the reported event will be addressed within 0001825034-2023-02585 only.
 
Event Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.The entirety of the reported event will be addressed within 0001825034-2023-02585 only.
 
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Brand Name
UNK DISTAL HUMERAL COMPONENT
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key18088119
MDR Text Key327566775
Report Number0001825034-2023-02587
Device Sequence Number1
Product Code PHX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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