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

Catalog Number	00434903603
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: item# 00434901013; lot# 67375014.E1: full establishment name: (b)(6).G2: foreign, event occurred in china.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.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during an implantation of the zimmer tmr reverse shoulder prosthesis, the augmented 3mm liner could not be inserted into the humeral stem.It was noted that it popped up when trying to press it in.Subsequently, a 6mm augmented liner was used instead with the same stem and inserted easily.No patient consequences were reported as a result of the event.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information 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/corrected: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6.Visual examination of the returned product identified signs of use.The edge of the device has scratches and gouges in multiple areas.There is positive material in one of the cutouts along the edge of the liner from damage.There are 3 locking fingers on the back of the device that have damage to the attaching feature.Verified etch and all product identifiers to confirm the device is conforming to print specifications.Medical records were not provided.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event was confirmed.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 23846211
• Report Number: 0001822565-2025-04606
• Device Sequence Number: 9959086
• Product Code: PHX
• UDI-Device Identifier: 00889024633063
• UDI-Public: (01)00889024633063(17)291112(10)66949083
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• 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
• Report Date (Section B): 06/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00434903603
• Device Lot Number: 66949083
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Patient Sex: Unknown