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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. S1S HIP NECK ADAPTER -6MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. S1S HIP NECK ADAPTER -6MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Joint Dislocation (2374)
Event Date 01/16/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown spacer mold, pn unknown, ln unknown. Multiple mdr reports were filed for this event. Please see reports: 0001825034-2019-00344. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient underwent a revision procedure due to the dislocation which was found while the drains for the previous infection were being changed. Attempts have been made and additional information on the reported event is unavailable at this time. No further information is available.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Concomitant medical products: item # unk, unknown stem spacer mold, lot # unk, item # unk, unknown head spacer mold, lot # unk. An additional report has been submitted for this event: 0001825034-2019-02021. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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 NameS1S HIP NECK ADAPTER -6MM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8288680
MDR Text Key134463996
Report Number0001825034-2019-00346
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
K080979
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Type of Report Initial,Followup
Report Date 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number431188
Device Lot Number100460
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/30/2019 Patient Sequence Number: 1
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