MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SHOULDER SYSTEM SHOULDER STEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	113651
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in china.E1: telephone: (b)(6).The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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
It was reported that during a comprehensive shoulder arthroplasty, a size 11 humeral stem could not be advanced and became stuck intra-operatively.During the procedure, the humerus was reamed for a size 11 standard stem and rasped with a size 11 humeral rasp.The implanted size 11 prosthesis could not advance by approximately 1 cm and could neither be fully inserted nor removed.After approximately 2 hours of unsuccessful attempts to adjust or remove the stem, the proximal humerus was split to facilitate removal, and a size 10 stem was subsequently implanted successfully.The patient was implanted with a size 10 humeral stem successfully.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information is available at the time of this report.
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; d9; g1; g3; g6; h1; h2; h3; h6 the reported event is confirmed through evaluation of medical records and the returned product.Visual examination of the returned product identified signs of damage and use.There are scratches/gouges on the mid-section of the stem as well as on the proximal end of the stem near the size etch.There is also some damage to the porous coating on the stem near the neck of the stem.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiograph was provided and reviewed by a health care professional.Review of the available record identified the following: there are post-operative changes of reverse total shoulder arthroplasty with long humeral stem and presumed proximal porous coating.The humeral stem is slight proud of the humeral head resection line compatible with the given history of incorrect implant seating.The humeral tray is not in place.Although absence of calibration limits exact measurement the humeral stem is visually proud of the greater tuberosity.The long humeral stem occupies nearly the entire humeral endosteal canal.No fracture is identified.A definitive root cause cannot be determined.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.

• Brand Name: COMPREHENSIVE SHOULDER SYSTEM SHOULDER STEM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: 23976057
• Report Number: 0001825034-2026-00064
• Device Sequence Number: 19971865
• Product Code: MBF
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 113651
• Device Lot Number: 66827000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown