MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK COONRAD MORREY HUMERAL; ELBOW, PROSTHESIS

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

Patient Problem Peripheral Nervous Injury (4414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: united kingdom.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01517.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product remains implanted.

Event Description

It was reported a patient developed radial nerve palsy post implantation and had an unknown procedure in order to allow the wrist to extend.The physician notes that there was extravasation of unknown cement, which is close to the radial nerve.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Proposed annex g code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient is now 68 years old and suffer with rheumatoid arthritis.This resulted in both of the patient's elbows being replaced around 2008/09.Later, the left side suffered early failure and the patient had a revision at wrightington.This ultimate performed well but the patient did experience what sounds like a radial nerve palsy post-surgery.After the initial revision operation the patient reported radial nerve palsy and had to have a small procedure in order to allow wrist extension.It is suspected this may have been a tendon transfer although we can't be sure.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.The reported event is not confirmed.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

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

• Brand Name: UNK COONRAD MORREY HUMERAL
• Type of Device: ELBOW, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17070670
• MDR Text Key: 316600390
• Report Number: 0001822565-2023-01516
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2023
• 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
• Patient Sequence Number: 1
• Treatment: UNK COONRAD MORREY ULNA; UNKNOWN CEMENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female