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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS 19CM DIAPHYSEAL SEGMENT; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. OSS 19CM DIAPHYSEAL SEGMENT; PROSTHESIS, KNEE Back to Search Results
Catalog Number 150472
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified.No patient or surgical involvement.No further information available at this time.
 
Manufacturer Narrative
It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.
 
Event Description
It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.
 
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Brand Name
OSS 19CM DIAPHYSEAL SEGMENT
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8734221
MDR Text Key149185098
Report Number0001825034-2019-02756
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
K123501
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/26/2019
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 Date08/28/2022
Device Catalogue Number150472
Device Lot Number883060
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/19/2019
Initial Date FDA Received06/26/2019
Supplement Dates Manufacturer Received08/23/2019
Supplement Dates FDA Received09/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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