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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
Catalog Number 00515048201
Device Problems Corroded (1131); Expulsion (2933)
Patient Problem No Patient Involvement (2645)
Event Date 05/13/2019
Event Type  malfunction  
Manufacturer Narrative
This event is recorded with zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that some liquid leaked from the battery.No adverse events were reported as a result of this malfunction.
 
Event Description
No additional event information available.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) for (b)(4), could not be performed as a lot number was not provided for the reported event.On 14 may 2019, it was reported from midorii orthopaedics that some liquid leaked from the battery of this product.A returned product investigation could not be performed for the reported event due to the product not being returned for evaluation.Photos of the device were provided by the account, however.The photos indicate that the a device had corrosion inside of the battery pack.These photos confirm the reported event.While the photos provided by the account confirmed that the (b)(4) had corrosion in the battery compartment, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
 
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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
MDR Report Key8625730
MDR Text Key145633771
Report Number0001526350-2019-00382
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/22/2019
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 Catalogue Number00515048201
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/14/2019
Initial Date FDA Received05/20/2019
Supplement Dates Manufacturer Received05/21/2019
Supplement Dates FDA Received05/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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