MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE; PROSTHESIS, SHOULDER

Catalog Number	00434903611
Medical Device Problem Codes	Material Erosion (1214); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Metal Related Pathology (4530)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 8 years post implantation due to metallosis and dislocation.The glenosphere was replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D6a: implant date - sometime in 2016.G2: france.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.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 8 years post implantation due to metallosis and dislocation.The glenosphere was replaced, as well as the poly liner.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.The following sections were updated: a1, a2, a3, a4, b4, b5, d10, g3, g6, h2, h11.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: 36mm ã¿ +3mm offset poly liner cat# 00434903603 lot# 63103105.12mm ã¿ 130mm length humeral stem cat# 00434901213 lot# 63171991.
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, h10, h11 h6: mechanical (g04) - head 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.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 is available at the time of this report.
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: 0001822565-2024-01899-3.0001822565-2024-03218-1.Visual examination of the returned product identified signs of use and wear and tear.The id of the glenosphere returned has some wear on the outer wall of the glenosphere.The od of the glenosphere has some scratches, wear and tear and some discoloration.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.The initial report was forwarded in error and should be voided as it is a duplicate event and has be.

• Brand Name: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE
• 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: 19384700
• Report Number: 0001822565-2024-01724
• Device Sequence Number: 17875629
• Product Code: KWT
• UDI-Device Identifier: 00889024269088
• UDI-Public: (01)00889024269088(17)250831(10)63133133
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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,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: 08/31/2025
• Device Catalogue Number: 00434903611
• Device Lot Number: 63133133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 05/31/2024; 10/02/2024; 11/07/2024; 07/23/2025
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/05/2024; 10/09/2024; 11/11/2024; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2015
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.; UNK POLY LINER.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 72 KG