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

Catalog Number	00434906606
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a reverse shoulder revision procedure approximately 5 months post-implantation due to component dilsocation.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in australia.Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.D10: concomitant medical products, part (lot): 110030777(66144236).Associated product information: 180559(62212850).115398(66508387).110032410(67109285).180552(67160072).180550(67221332).180550(67232909).00-4349-016-13(66866727).The customer has not indicated whether the product will be zimmer biomet for investigation, and the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; b7; d2; d4; d9; g1; g3; g6; h1; h2; h3; h4; h10.The reported event cannot be confirmed.Visual examination of the provided photos identified the explanted products with signs of use and biological debris.However, as the products were not returned, further analysis could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The root cause of the reported issue is attributed to patient non-compliance.It was indicated that the patient admitted to lifting and carrying weights in excess of the surgeons' direct orders.Ifu indicates "patients should be warned of the impact of excessive loading that can result if the patient is involved in an occupation that includes substantial lifting, or excessive muscle loading due to weight that places extreme demands on the shoulder and can result in device failure or dislocation." 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 that the patient underwent a shoulder revision approximately five months post-implantation due to dislocation with humeral polyethylene liner dissociation.Approximately seven weeks after the initial procedure, the patient lifted and carried weights contrary to post-operative restrictions and sustained a dislocation.The patient presented to an emergency department where closed reduction was attempted for a couple of hours.The treating surgeon believed that the prolonged reduction attempts contributed to dissociation of the humeral polyethylene liner, which led to the subsequent revision.It was reported that no further information is available.

• Brand Name: TRABECULAR METAL REVERSE SHOULDER SYSTEM POLY LINER
• 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: 23693781
• Report Number: 0001822565-2025-04352
• Device Sequence Number: 21426445
• Product Code: PHX
• UDI-Device Identifier: 00889024633162
• UDI-Public: (01)00889024633162(17)290528(10)66623400
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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 Catalogue Number: 00434906606
• Device Lot Number: 66623400
• Was Device Available for Evaluation?: No
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male