MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM Ã +6MM OFFSET POLY LINER; PROSTHESIS, SHOULDER

Catalog Number	00434903606
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00434903611 36mm ã glenosphere 63930225; unknown screw.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 03338, 0001822565 - 2023 - 03350.
Event or Problem Description
It was reported that the patient was revised due to the nerve pain caused by the superior screw being too long.No additional patient consequences were reported.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: 36MM Ã +6MM OFFSET POLY LINER
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; indiana IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; indiana IN 46580
• Manufacturer Contact: jennifer rapsavage ; 1800 w. center st.; indiana, IN 46580
• MDR Report Key: 18212878
• Report Number: 0001822565-2023-03337
• Device Sequence Number: 20668896
• Product Code: HSD
• UDI-Device Identifier: 00889024269071
• UDI-Public: (01)00889024269071(17)260531(10)63842505
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K052906
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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: 05/31/2023
• Device Catalogue Number: 00434903606
• Device Lot Number: 63842505
• 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): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/25/2024
• Date Device Manufactured: 06/06/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown