MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 40MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER; PROSTHESIS, SHOULDER

Catalog Number	00434906606
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 12mm humeral stem spacer cat# 00434903912 lot# 64350832.+2mm lateral offset 25mm post length base plate cat# 00434902502 lot# 64227277 40mm glenosphere cat# 00434904011 lot# 64207893 14mm 130mm length humeral stem cat# 00434901413 lot# 64227602.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 is being considered for a shoulder revision procedure due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was further reported that the patient is being considered for a revision due to dislocation.No revision procedure has been reported to date.Attempts have been made and 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 corrected/updated: b1, b4, b5, g3, g6, h2, h6, h11.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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, h4, h6, h11.No product was returned or pictures provided of the devices; visual and dimensional evaluations could not be performed.Photos of usage only were provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.The single x-ray view was reviewed and not submitted to radiology for review as the image is undated was unable to correlate with the event of dislocation.A definitive root cause cannot be determined.The reported event is unconfirmed.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.

• Brand Name: 40MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER
• 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: 22234639
• Report Number: 0001822565-2025-01974
• Device Sequence Number: 21106791
• Product Code: KWS
• UDI-Device Identifier: 00889024269224
• UDI-Public: (01)00889024269224(17)261031(10)63953087
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2025

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 Catalogue Number: 00434906606
• Device Lot Number: 63953087
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 10/01/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/10/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2018
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male