MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 40MM ÿ +3MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER; SHOULDER GLENOID FOSSA PROSTHESIS, PREFABRICATED

Catalog Number	00434906603
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: glenosphere eccentric 40 mm diameter +3 mm lateral offset cat#00436304025 lot#64423332.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 - 02723.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 13 months post implantation due to dislocation.The poly liner, glenosphere, and tray were replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: 9mm humeral stem spacer cat#: 00434903909, lot#: 65341647.The reported event is not confirmed.The returned product shows damage on the products, but there are no medical records or x-rays to confirm disassociation or dislocation.Visual examination of the returned product identified the poly liner shows damage in the spherical radius and backside.Dhr shows the mating features that accept the poly liner are 100% inspected on a cmm at the time of manufacture ¿ all devices were conforming to print specifications.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00462.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 40MM ÿ +3MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER
• Common Device Name: SHOULDER GLENOID FOSSA PROSTHESIS, PREFABRICATED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17870768
• Report Number: 0001822565-2023-02722
• Device Sequence Number: 12522958
• Product Code: KWT
• UDI-Device Identifier: 00889024269217
• UDI-Public: (01)00889024269217(17)240229(10)63234716
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 00434906603
• Device Lot Number: 63234716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2016
• 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.; SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown