MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD RGX AUG - SM; COMPREHENSIVE SRS MODULAR REGENEREX AUGMENT

Catalog Number	211228
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products, part (lot): associated product information: -211218 (125640).-115313 (624810).-211244 (739250).-110027734 (136100).-211228 (480440).Associated product information, part (lot) -110031400 (64263046).-110031426 (64291230).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 that a patient entered clinical study upon revision of right rtsa with repair of commuted humeral fracture.Subsequently, the patient experienced ongoing pain with no identified implant abnormalities and received injection approximately 4 years post-implantation with resolution.Remains implanted at study completion.
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; d4; e1; e2; e3; g1; g3; g6; h1; h2; h3; h6; h10 the reported event is not confirmed.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 related to the reported event.Crfs were provided and reviewed by a health care professional.Review of the available records identified the following: persistent pain and muscle tenderness near cable fasteners.Xray/ct showed no hardware issues ; ot prescribed.Again ongoing pain, xray ¿ no hardware issues.Trigger point injection given.Mri ¿ negative.Symptoms gradually resolved without intervention.Study completion, remains implanted.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMPR SRS MOD RGX AUG - SM
• Common Device Name: COMPREHENSIVE SRS MODULAR REGENEREX AUGMENT
• 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: 22621111
• Report Number: 0001825034-2025-02245
• Device Sequence Number: 8932563
• Product Code: PHX
• UDI-Device Identifier: 00880304507876
• UDI-Public: (01)00880304507876(17)290417(10)480440
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173411
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 211228
• Device Lot Number: 480440
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2019
• 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: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White