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

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Foreign Body Reaction (1868); Failure of Implant (1924); Pain (1994); Tissue Damage (2104)

Event Date 01/14/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).(udi): n/a.Medical product: catalog #: 11-210063, explor 8x28mm impl stem w/scr, lot # 543210.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.Location unknown.

Event Description

It was reported that a patient underwent an explor elbow arthroplasty approximately 10 years ago.Subsequently, the patient was revised about 2 months ago due to the locking screw backing out, pain, tissue damage, and metallosis.

Manufacturer Narrative

(b)(4).Reported event was considered confirmed as the x-rays showed loosening of the radial head with dissociated screw as well as a small fracture throughout the radius.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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: 0001825034-2019-05821.

Event Description

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

• Brand Name: UNKNOWN HEAD
• Type of Device: PROSTHESIS ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10282693
• MDR Text Key: 199985056
• Report Number: 0001825034-2020-02767
• Device Sequence Number: 1
• Product Code: JDB
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• 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: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention