MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5MM CORT. SCREW 24MM LNG S; PROSTHESIS, SCREW

Catalog Number	47483502401
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Complex regional pain syndrome (4899)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: one-third tubular plt 4 hole cat# 47493500403 lot # 64980726.One-third tubular plt 10 hole cat# 47493501003 lot # 65039919.4.0 x 40 part thd canc scr cat# 47484004001 lot # 64768001.4.0 x 35 part thd canc scr cat# 47484003501 lot # 63635448.3.5mm cort.Screw 16mm lng s cat# 47483501601 lot # 65960879.3.5mm cort.Screw 16mm lng s cat# 47483501601 lot # 65960879.3.5mm cort.Screw 16mm lng s cat# 47483501601 lot # 65960879.3.5mm cort.Screw 16mm lng s cat# 47483501601 lot # 65960879.3.5mm cort.Screw 16mm lng s cat# 47483501601 lot # 65601975.3.5mm cort.Screw 14mm lng s cat# 47483501401 lot # 65514783.3.5mm cort.Screw 20mm lng s cat# 47483502001 lot # 64939904.3.5mm cort.Screw 18mm lng s cat# 47483501801 lot # 65901451.3.5mm cort.Screw 28mm lng s cat# 47483502801 lot # 64913111.4.0 x 14 cancell.Screw cat# 47484001400 lot # 65335756.G2: united kingdom.The complaint cannot be confirmed due to lack of information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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
It was reported that a clinical study patient experienced complex regional pain syndrome approximately two months post-implantation.The symptoms subsequently resolved and the device remained implanted.Attempts have been made and no further information has been provided.

• Brand Name: 3.5MM CORT. SCREW 24MM LNG S
• Common Device Name: PROSTHESIS, SCREW
• 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: 24326982
• Report Number: 0001822565-2026-00496
• Device Sequence Number: 13180351
• Product Code: HTN
• UDI-Device Identifier: 00889024101074
• UDI-Public: (01)00889024101074(17)320229(10)65271221
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 47483502401
• Device Lot Number: 65271221
• 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: 02/03/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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 Age: 53 YR
• Patient Sex: Male