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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SRS; PROSTHESIS, SHOULDER

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ZIMMER BIOMET, INC. UNKNOWN SRS; PROSTHESIS, SHOULDER Back to Search Results
Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); 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  
Manufacturer Narrative
(b)(4).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 - 02586; 0001825034 - 2023 - 02587; 0001825034 - 2023 - 02588.
 
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.
 
Event Description
No further event information is available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.The reported event is unconfirmed.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
UNKNOWN SRS
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 Key18086339
MDR Text Key327554654
Report Number0001825034-2023-02585
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
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
Initial Date Manufacturer Received 10/20/2023
Initial Date FDA Received11/07/2023
Supplement Dates Manufacturer Received01/09/2024
Supplement Dates FDA Received01/11/2024
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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