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

Catalog Number	00430902900
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.The reported event is confirmed though analysis of returned product.Visual examination of the returned product/provided pictures identified signs of use and wear and tear.The polished surface of the impactor is scratched and there is a gouge on the od of the impactor.There are some stains and wear and tear on the bottom side of the impactor as well.The post has fractured off the impactor and it has been returned.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 that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found 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 the poly impactor post fractured off during ex situ impaction.The case was able to be completed with the impactor.No complications, injuries, or surgical.Interventions were reported, and no foreign bodies were reported retained due to this malfunction.It was reported that no further information is available.

• Brand Name: TRABECULAR METAL REVERSE SHOULDER SYSTEM LINER IMPACTOR
• 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: 23017401
• Report Number: 0001822565-2025-03362
• Device Sequence Number: 9511712
• Product Code: PHX
• UDI-Device Identifier: 00889024267336
• UDI-Public: (01)00889024267336(10)63870394
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: 00430902900
• Device Lot Number: 63870394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female