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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER STANDARD OFFSET; PROSTHESIS, HIP
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ZIMMER MANUFACTURING B.V. LINER STANDARD OFFSET; 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.
 
Manufacturer Narrative
It was determined this device did not cause or contribute to any reportable malfunction.Please void this submission.
 
Event Description
It was determined this device did not cause or contribute to any reportable malfunction.Please void this submission.
 
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Brand Name
LINER STANDARD OFFSET
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
MDR Report Key8417801
MDR Text Key138771037
Report Number0002648920-2019-00198
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K002960
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 08/02/2019
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 Date01/31/2023
Device Model NumberN/A
Device Catalogue Number00630505836
Device Lot Number63916376
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/21/2019
Initial Date FDA Received03/13/2019
Supplement Dates Manufacturer Received08/01/2019
Supplement Dates FDA Received08/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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