MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 12MM ÿ 130MM LENGTH HUMERAL STEM; PROSTHESIS, SHOULDER

Catalog Number	00434901213
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Metal Related Pathology (4530)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D6a: sometime in 2016.D10: 36mm ã¿ glenosphere cat# 00434903611 lot# 63133133.36mm ã¿ +3mm offset poly liner cat# 00434903603 lot# 63103105.G2: france.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 8 years post implantation due to metallosis, dislocation, as well as stem/liner disassociation.The glenosphere was replaced, as well as the poly liner.Attempts have been made and no additional info is available at this time.
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.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.H6: mechanical (g04) stem.Visual examination of the provided picture identified a glenopshere and poly.The image does not confirm the reported event.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.The reported event is not confirmed.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 available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.The following section was corrected: d9.H10: related report number: 0001822565-2024-01724-3.0001822565-2024-01899-3.Visual examination of the provided picture identified a glenopshere and poly.The image does not confirm the reported event.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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: 12MM ÿ 130MM LENGTH HUMERAL STEM
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 20410711
• Report Number: 0001822565-2024-03218
• Device Sequence Number: 9044557
• Product Code: PHX
• UDI-Device Identifier: 00889024268951
• UDI-Public: (01)00889024268951(17)250930(10)63171991
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2025

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: Lay User/Patient
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 00434901213
• Device Lot Number: 63171991
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 07/23/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/11/2024; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 72 KG