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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES POROUS; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES POROUS; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Shipping Damage or Problem (1570)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported by the distributor the product arrived damaged with sterility barrier potentially compromised.There was no patient involvement.
 
Event Description
No further information available at the time of this reporting.
 
Manufacturer Narrative
It was identified in investigation this device did not cause or contribute to any serious injury or reportable malfunction.Investigation identified that the sterility of the package was not compromised.Please consider this submission void.
 
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Brand Name
SHELL WITH CLUSTER HOLES POROUS
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8548649
MDR Text Key143047937
Report Number0001822565-2019-01711
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K151448
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00875705601
Device Lot Number64108702
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2019
Was the Report Sent to FDA? No
Date Manufacturer Received06/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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