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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE ULNAR ASSEMBLY EXTRA SMALL RIGHT LONG 4.5 INCH LENGTH; PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. INTERCHANGEABLE ULNAR ASSEMBLY EXTRA SMALL RIGHT LONG 4.5 INCH LENGTH; PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problems Rheumatoid Arthritis (1724); Bone Fracture(s) (1870); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
(b)(4).(b)(6).Unique identifier (udi) #: n/a.Customer has indicated that the product will not be returned to zimmer biomet for investigation, remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient was recommended for a revision of the right elbow due to patient bone fracture and loosening of implant.Attempts were made and no additional information is available at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Concomitant medical products: unknown humeral stem ¿ unknown part unknown lot therapy date: unknown.(b)(4).Reported event was confirmed by review of x-rays provided.Review of x-rays notes ossific material adjacent to the proximal ulna medially and anteriorly reflecting prior fracture or heterotopic ossification.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 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08563.
 
Event Description
It was reported that the patient underwent a revision of the right elbow due to patient bone fracture and loosening of implant at an unknown amount of time post implantation.Attempts were made and no additional information is available at this time.
 
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Brand Name
INTERCHANGEABLE ULNAR ASSEMBLY EXTRA SMALL RIGHT LONG 4.5 INCH LENGTH
Type of Device
PROSTHESIS, 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 Key7776642
MDR Text Key116885439
Report Number0001822565-2018-03496
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
PK001989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number32810509302
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/22/2018
Initial Date FDA Received08/13/2018
Supplement Dates Manufacturer Received08/09/2018
Supplement Dates FDA Received08/30/2018
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 Sequence Number1
Patient Outcome(s) Other;
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