MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MD HYBRID GLENOID BASE 4MM; SHOULDER, PROSTHESIS

Model Number N/A

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

Patient Problem Peripheral Nervous Injury (4414)

Event Date 08/09/2022

Event Type  Injury  

Event Description

It was reported that a study patient underwent an anatomic shoulder arthroplasty.Immediately postoperative, the patient was noted to have radial nerve palsy as diagnosed by drop hand.The patient underwent emg and radiologic diagnostics.The patient started using a drop hand splint/ brace and physiotherapy was started.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4).Concomitant medical products: humeral stem cemented dia9-100 cat: 01.04211.093 lot: 3042273, dome centric cat: 01.04227.005 lot: 2999731, humeral head dia46-16 cat: 01.04212.465 lot: 3092254.Foreign source: belgium.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

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.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.

• Brand Name: MD HYBRID GLENOID BASE 4MM
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16326239
• MDR Text Key: 309070818
• Report Number: 0001825034-2023-00270
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304462489
• UDI-Public: (01)00880304462489(17)260823(10)243210
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K060694
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113954
• Device Lot Number: 243210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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: SEE H10.
• Patient Outcome(s): Disability