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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN DISCOVERY HUMERAL PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. UNKNOWN DISCOVERY HUMERAL PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Bone Fracture(s) (1870); No Code Available (3191)
Event Date 09/23/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown, unknown discovery ulna, unknown; unknown, unknown condyles, unknown. Report source, foreign - the event occurred in the (b)(6). Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 01240. Product location unknown.
 
Event Description
It was reported that a patient underwent right elbow arthroplasty. Subsequently, the patient was revised due to aseptic loosening. Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
(b)(4). This follow-up report is being submitted to relay additional information. Implant date - the device was not implanted on (b)(6) 2013. Reported event was unable to be confirmed due to limited information received from the customer. X-rays were submitted to mmi for review. Images are such poor quality that they could not evaluate. They suggest alignment is correct. Bone quality suggests osteopenia which is consistent with the patient's diagnosis of osteoporosis and rheumatoid arthritis. Device history record (dhr) review was unable to be performed as the part and lot numbers of the device involved in the event are unknown. 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.
 
Event Description
It was reported that a patient underwent right elbow arthroplasty. Subsequently, the patient was revised due to aseptic loosening. The loosening over both humeral and ulnar components caused the periprosthetic fracture. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameUNKNOWN DISCOVERY HUMERAL
Type of DevicePROSTHESIS, ELBOW
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7288106
MDR Text Key100646866
Report Number0001825034-2018-01239
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
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 Received05/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/21/2018 Patient Sequence Number: 1
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