MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER; PROSTHESIS, SHOULDER

Catalog Number	00434906506
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a revision due to disassociation.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to location of device is unknown.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 -2022 -00073.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10:tm reverse stem 14mm x 130mm cat# 00434906506 lot# 64841033 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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.
Event or Problem Description
No additional information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The additional information does not change the root cause of the previous investigation.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 or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 36MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13259001
• Report Number: 0001822565-2022-00071
• Device Sequence Number: 4760780
• Product Code: KWT
• UDI-Device Identifier: 00889024269194
• UDI-Public: (01)00889024269194(17)290503(10)64841033
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/02/2022
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 00434906506
• Device Lot Number: 64841033
• 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: 12/18/2021
• Supplement Date Received by Manufacturer: 04/27/2022; 08/29/2022; 08/04/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 05/11/2022; 09/01/2022; 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Male