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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DIST HUM POSLAT R 11H 94MM ST; SHOULDER, PROSTHESIS
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ZIMMER BIOMET, INC. DIST HUM POSLAT R 11H 94MM ST; SHOULDER, PROSTHESIS Back to Search Results
Catalog Number 851318301
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).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 report will be submitted.Product not returned.
 
Event Description
It was reported that debris was found in the sterile package at incoming inspection.There was no patient involvement.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d10, g4, g7, h1, h2, h3, h6, h10 visual examination of the returned product/provided pictures found a hair-like debris in the sterile packaging.Device history record was reviewed and no discrepancies were found.The condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the work instructions 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.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
DIST HUM POSLAT R 11H 94MM ST
Type of Device
SHOULDER, PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11931385
MDR Text Key254060473
Report Number0001825034-2021-01710
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number851318301
Device Lot Number915540
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2021
Was the Report Sent to FDA? No
Date Manufacturer Received07/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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