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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIP KIT; LAVAGE, JET

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ZIMMER SURGICAL, INC. HIP KIT; LAVAGE, JET Back to Search Results
Model Number N/A
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2023
Event Type  malfunction  
Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.E1 telephone number: (b)(6).G2 country: denmark.
 
Event Description
It was reported that during surgery when the packaging was opened, there were small white particles attached to the hose in the box.The box was discarded, and another device was utilized to complete the procedure.There was no patient impact or delay noted.Due diligence is complete and there is no additional information available.There was no adverse event associated with the malfunction.
 
Event Description
There is no additional information available regarding the event.
 
Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).No product was returned.Pictures were provided that show the device was opened with white particulate on the tubing.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event cannot be confirmed as the sterile packaging was opened.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
HIP KIT
Type of Device
LAVAGE, JET
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer (Section G)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer Contact
jennifer rapsavage
56 e. bell drive
warsaw, IN 46582
5745260384
MDR Report Key18229018
MDR Text Key329262704
Report Number0001526350-2023-01553
Device Sequence Number1
Product Code FQH
UDI-Device Identifier00889024375208
UDI-Public(01)00889024375208(17)260430(10)69766570
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00515048601
Device Lot Number69766570
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/17/2023
Initial Date FDA Received11/29/2023
Supplement Dates Manufacturer Received02/22/2024
Supplement Dates FDA Received02/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient SexPrefer Not To Disclose
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