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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peripheral Nervous Injury (4414)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.
Additional 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
• Common Device Name: 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
• Report Number: 0001825034-2023-00270
• Device Sequence Number: 8657925
• Product Code: HSD
• UDI-Device Identifier: 00880304462489
• UDI-Public: (01)00880304462489(17)260823(10)243210
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K060694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown