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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. INTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE ONLY REGULAR PROSTHESIS, ELBOW

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ZIMMER, INC. INTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE ONLY REGULAR PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 08/01/2016
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. 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
Reported event was unable to be confirmed due to limited information received from the customer. Radiographic evaluation evidenced signs of poly wear and component migration but fracture could not be confirmed. The device history record was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. A definite root cause cannot be determined with the information provided, however, the patient doesn't deny sport activities which may have contributed to event. 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). It is unknown at this time if the device is being returned for evaluation, the investigation has been started and if the device is received, an evaluation will be performed and a follow up will be submitted. Concomitant medical products: catalog number 32810506302, lot number 62774233, interchangeable ulnar assembly for cemented use only regular right. Multiple mdr reports were filed for this event, please see associated reports: 1822565-2017-01747 & 01776.
 
Event Description
It was reported that the patient underwent a right elbow arthroplasty procedure and approximately fifteen (15) months post-implantation the articulate pin fractured. Subsequently, the patient was revised twenty-one (21) months post-implantation. Operative notes indicated 2 ml of clear synovial fluid discharged from the joint cavity, the pin was destroyed and the polyethylene insert components were worn. The pin and inserts were removed and replaced.
 
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Brand NameINTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE ONLY REGULAR
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 Key6414789
MDR Text Key112592746
Report Number0001822565-2017-01747
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeRS
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,Followup
Report Date 09/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberN/A
Device Catalogue Number32810502604
Device Lot Number62790393
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 Received09/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/14/2014
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: 03/17/2017 Patient Sequence Number: 1
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