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

Model Number	113954
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: versa-dial/comp ti std taper, cat #: 118001, lot #: 264620; versa-dial 54x24x58 hum head, cat #: 113065, lot #: 394810; pt hybrid glen post regenerex, cat #: pt-113950, lot #: 918860; comp primary stem 16mm mini, cat #: 113636, lot #: 733320.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.
Event or Problem Description
It was reported that the patient was revised due to wear.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
The reported event was able to be confirmed by review of the provided photographs.Visual examination of the pictures identified that the poly appears to be worn and covered with biodebris.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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: 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: 17210739
• Report Number: 0001825034-2023-01430
• Device Sequence Number: 17809151
• Product Code: HSD
• UDI-Device Identifier: 00880304462489
• UDI-Public: (01)00880304462489(17)220509(10)296400
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2022
• Device Model Number: 113954
• Device Catalogue Number: 113954
• Device Lot Number: 296400
• 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: 06/01/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2017
• 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: Required Intervention; Hospitalization
• Patient Sex: Male