MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR MODULAR RADIAL HEAD; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical device: explor 9x30mm impl stem w/scr pn11-210064 ln011400.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause related to patient's allergy to nickel.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 the patient underwent an initial left elbow arthroplasty.Subsequently, the patient was diagnosed with a nickel allergy and is being considered for a revision.Attempts have been made and additional information on the reported event is unavailable.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: a2; a3; b4; b5; d7; g4; g7; h1; h2; h3; h6.No device or photos were received; therefore the condition of the component is unknown.Per surgical technique, the implants on this complaint are compatible with one another.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Received information does not change previously determined root cause.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 MODULAR RADIAL HEAD
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7421146
• MDR Text Key: 105144320
• Report Number: 0001825034-2018-02190
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: PK040611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 11-210043
• Device Lot Number: 806380
• Other Device ID Number: (01) 0 0880304 43833 0
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other