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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. INTERCHANGEABLE HUMERAL ASSEMBLY PROSTHESIS, ELBOW

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ZIMMER, INC. INTERCHANGEABLE HUMERAL ASSEMBLY PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 01/21/2014
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer, however, review of provided radiograph found radiolucency at the humeral stem which is consistent with loosening and noted the humeral component stem is off-center medially and posteriorly within the humeral canal, with nonuniform cement mantle, which may have contributed to loosening of the humeral component. Dhr was reviewed and no discrepancies were found. 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 will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet as they are probably discarded. The investigation is in process. Once the investigation has been completed a follow up mdr will be submitted.
 
Event Description
It is reported that patient was revised due to unknown reasons. Attempts have been made and additional information is not available at this time.
 
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Brand NameINTERCHANGEABLE HUMERAL ASSEMBLY
Type of DevicePROSTHESIS, ELBOW
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 Key6848661
MDR Text Key133974019
Report Number0001822565-2017-06327
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PK001989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2012
Device Model NumberN/A
Device Catalogue Number32810503506
Device Lot Number60669418
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 Received11/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2007
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/07/2017 Patient Sequence Number: 1
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