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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COONRAD-MORREY HUMERAL COMPONENT PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. UNKNOWN COONRAD-MORREY HUMERAL COMPONENT PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Noise, Audible (3273); Migration (4003)
Patient Problems Pain (1994); Osteolysis (2377)
Event Date 02/23/2012
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Unique identifier (udi) #: n/a. Initial implant date: unknown date, 2006. Concomitant medical products: part # unk, ulnar component, lot # unk. Event occurred in (b)(6). Multiple mdr reports were filed for this event; please see associated reports: 0001822565-2018-06454.
 
Event Description
It was reported that approximately six (6) years post implantation, the patient underwent a r elbow revision due to pain and implant squeaking/noise. During the procedure, polyethylene wear, distal humeral osteolysis, and a loose humeral component were noted. The humeral component and bushings were removed and replaced. Attempts are in process, and no further information has been provided.
 
Manufacturer Narrative
Reported event was confirmed by review of medical records. Operative findings noted poly wear and localized distal humeral osteolysis. Patient also had a loose humeral component. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. A definite root cause cannot be determined with the information 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.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameUNKNOWN COONRAD-MORREY HUMERAL COMPONENT
Type of DevicePROSTHESIS, ELBOW
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8071364
MDR Text Key127157479
Report Number0001822565-2018-06453
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/18/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/14/2018 Patient Sequence Number: 1
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