MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ULNAR; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi: n/a.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001822565-2020-01907.Location unknown.

Event Description

It was reported by a journal article from a year ago that studied total elbow arthroplasty failure rates of forty-six (46) patients.Six (6) patients underwent revision due to periprosthetic fracture of which five (5) experienced fracture around the humeral component and one (1) required revision of both the humeral and ulnar component as the ulnar component was noted to be loose.

Manufacturer Narrative

(b)(4).Updated: b4, b5, g4, h1, h2, h6, and h10.Bebernardis da, horneff jg, davis de, ramsey ml, pontes mc, austin ls.Revision total elbow arthroplasty failure rates: the impact of primary arthroplasty failure etiology on subsequent revisions.The journal of shoulder and elbow surgery (2019).Https://doi.Org/10.1016/j.Jse.2019.10.010.Reported event was unable to be confirmed due to limited information received from the customer.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.- attachment: [j shoulder elbow surg 2019 1 to 8.Pdf].

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN ULNAR
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10114723
• MDR Text Key: 193653791
• Report Number: 0001822565-2020-01982
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HUMERAL.; UNKNOWN HUMERAL
• Patient Outcome(s): Hospitalization; Required Intervention