MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X15 ST; PROSTHESIS, SCREW

Catalog Number	180550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: comp primary stem 10mm mini cat#: 113630, lot#: 381700, comp aug mini bsplt w tpr sm cat#: 110032410, lot#: 64370721, comp rvs cntrl 6.5x20mm st/rst cat#: 115394, lot#: 599250, comp lk scr 3.5hex 4.75x30 st cat#: 180553, lot#: 501970, comp lk scr 3.5hex 4.75x15 st cat#: 180550, lot#: 885030, comp lk scr 3.5hex 4.75x30 st cat#: 180553, lot#: 050120, comp rvrs shldr glnsp std 36mm cat#: 115310, lot#: 930660.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 from a clinical study that a patient had a right reverse total shoulder arthroplasty performed approximately 5.5 years ago.The patient did very well throughout the study until reporting severe pain and instability with activities at the 5 year follow up.No treatment or intervention has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
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 updated: b4, b5, e1, e2, e3, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Crfs were provided were provided and reviewed by a health care professional.Review of the available records identified the following: [6 weeks post op] x-rays normal.No instability, pain 8.5/10, ases 29.2.Slight pain, no problems.[6 months post op] x-rays normal.No instability, pain 2.1/10, ases 79.5.Slight pain with moderate problems while walking.[2 years post op] x-rays normal.No instability, pain 0/10, ases 85.Moderate pain with slight problems while walking.[3 years post op] x-rays normal.No instability, pain 0/10, ases 81.7.Slight pain, with moderate problems during usual activity and walking.[5 years post op] x-rays normal.Instability 9/10, pain 8.5/10, ases 30.8.Moderate pain and problems while walking, with slight problems washing/dressing and doing usual activities.Ae: pain with activities, no treatment or intervention noted.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.

• Brand Name: COMP LK SCR 3.5HEX 4.75X15 ST
• Common Device Name: PROSTHESIS, SCREW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21734195
• Report Number: 0001825034-2025-00897
• Device Sequence Number: 15637267
• Product Code: PHX
• UDI-Device Identifier: 00880304677135
• UDI-Public: (01)00880304677135(17)290716(10)966350
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 180550
• Device Lot Number: 966350
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2019
• 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: Female
• Patient Weight: 58 KG
• Patient Race: White