MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 8X28MM IMPL STEM W/SCR; PROSTHESIS, ELBOW

Catalog Number 11-210063

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi# (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the patient underwent an initial left radial head replacement.Approximately 4.5 years later, the patient was revised due to increasing pain, stiffness, instability, and limited mobility.While debriding the canal, a small bone fracture occurred in the proximal radius.Cerclage wires were used for stabilization, and the procedure was completed without further complication.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial op notes were reviewed and no complications were noted.Revision op notes were reviewed and identified the patient was revised due to increasing pain, stiffness, instability, and limited mobility.During the revision, it was noted that the screw was loose and not attached.All components were replaced.While debriding the radial canal, in the process there was a 4x5mm proximal edge chip off the proximal most radius but there remained a residual ¾ circumference intact sufficient to give good stability.Stabilized with cerclage wires.Follow up xray review: small 5th digit fingernail sized chip in the proximal edge of the radius but everything looks solid aligned.Review of the device history records identified no related deviations or anomalies during manufacturing.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.

• Brand Name: EXPLOR 8X28MM IMPL STEM W/SCR
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9916425
• MDR Text Key: 186749611
• Report Number: 0001825034-2020-01398
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K040611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2024
• Device Catalogue Number: 11-210063
• Device Lot Number: 393080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 133