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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PULSAVAC + HIP KIT 10/BOX; LAVAGE, JET

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ZIMMER SURGICAL, INC. PULSAVAC + HIP KIT 10/BOX; LAVAGE, JET Back to Search Results
Catalog Number 00515048200
Device Problem Expulsion (2933)
Patient Problem No Patient Involvement (2645)
Event Date 02/22/2019
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded under zimmer biomet complaint number (b)(4).The device has been returned for evaluation and investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.
 
Event Description
The customer reported that before using the product the operators noticed that the battery housing has increased in volume with leak of the content in the packaging.Another device has been used.No adverse events have been recorded as a result of this malfunction.
 
Event Description
No additional information received.
 
Manufacturer Narrative
This event has been recorded under zimmer biomet complaint number (b)(4).Udi# (b)(4).The following section has been updated: b5,d4,g4,g7,h2,h3, h4, h6, h10 the device history record (dhr) for 00515048200 lot number 29370093, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On (b)(6) 2019, it was reported from (b)(6) that the customer reported that before using the product the operators noticed that the battery housing has increased in volume with leak of the content in the packaging.On 25 march 2019, a returned product investigation was performed on the 00515048200.The physical evaluation revealed that the battery had ruptured inside of the packaging.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the 00515048200 batteries had ruptured inside of device packaging, 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
PULSAVAC + HIP KIT 10/BOX
Type of Device
LAVAGE, JET
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
MDR Report Key8452393
MDR Text Key139869817
Report Number0001526350-2019-00192
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 05/10/2019
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 Expiration Date09/30/2021
Device Catalogue Number00515048200
Device Lot Number29370093
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/01/2019
Initial Date FDA Received03/26/2019
Supplement Dates Manufacturer Received05/09/2019
Supplement Dates FDA Received05/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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