MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SRS MODULAR STEM; PROSTHESIS, SHOULDER, NON-CONSTRAINED

Catalog Number	211240
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item# 110029938; lot# 116420, item# 00840002411; lot# 63171877, item# 00840009500; lot# 66458918, item# 00840009000; lot# 66462812.G2: foreign - event occurred in australia.H6: proposed component code - mechanical (g04) - stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but not returned by the hospital.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent an elbow revision approximately seven (7) months post-implantation due to squeaking of elbow and excessive rom.The surgeon originally planned to revise distal body; however, the whole implant was loose and was removed and replaced.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10.H6: proposed component code - mechanical (g04) - stem.Visual examination of the provided pictures identified the implant construct after it was explanted.Bio-debris is present on the implants.No part or lot information is pictured.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: two views of the right humerus and elbow demonstrate a right elbow arthroplasty with three proximal cerclage wires.No radiolucency is noted.On the lateral film, there is an ossific density at the level of the olecranon which is not seen on ap film.No definite loosening is seen.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event is not confirmed.If any further information 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
No further event information available at the time of this report.

• Brand Name: COMPREHENSIVE SRS MODULAR STEM
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED
• 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: 21898701
• Report Number: 0001825034-2025-01191
• Device Sequence Number: 12805456
• Product Code: KWT
• UDI-Device Identifier: 00880304540637
• UDI-Public: (01)00880304540637(17)330828(10)66114653
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K223631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: 211240
• Device Lot Number: 66114653
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Unknown