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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. TRILOGY SHELL WITH CLUSTER HOLES PROSTHESIS, HIP

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ZIMMER, INC. TRILOGY SHELL WITH CLUSTER HOLES PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Disassembly (1168)
Patient Problem No Information (3190)
Event Date 01/12/2015
Event Type  Injury  
Manufacturer Narrative
The following could not be completed with the limited information provided. Initial reporter - ni.
 
Event Description
It is reported that the patient's hip arthroplasty was revised one month post op due to disassociation of the acetabular liner.
 
Manufacturer Narrative
This follow up report is being filed to relay updated and additional information. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) was reviewed and no discrepancies were found relevant to the reported event. Review of the complaint history determined that no further action is required. 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 report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Manufacturer Narrative
This follow up report is being filed to relay corrected, updated and additional information. This information does not change the previously submitted investigation. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
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Brand NameTRILOGY SHELL WITH CLUSTER HOLES
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6376973
MDR Text Key69034753
Report Number0001822565-2017-01477
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number65875305801
Device Lot Number62739207
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/03/2017 Patient Sequence Number: 1
Treatment
ITEM#00811400230, CPT STEM, LOT#62722830
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