MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SHOULDER SYSTEM MINI HUMERAL STEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED

Catalog Number	113626
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item# 41-406805; lot# unknown.Item# 41-406806; lot# unknown.G2: foreign - event occurred in the netherlands.H6: proposed component code - mechanical (g04) - stem.Customer has indicated that the product is in 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 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 during an initial shoulder arthroplasty, the placement of the stem was unsuccessful.It was noted that it was not possible to insert the stem deeply enough into the humeral shaft.Subsequently, repeated reaming also yielded no improvement.Due to excessive tension, avulsion of the conjoined rotator cuff tendon occurred.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; d9; g1; g3; g6; h1; h2; h3; h6; h10.Visual examination of the returned product/provided pictures identified signs of implantation (dings around the extraction hole and a foreign substance adhered to the porous coat.The product features, where measured, are conforming to print specifications.Medical records were not provided.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 event was unable to be 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 SHOULDER SYSTEM MINI HUMERAL STEM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: 22646882
• Report Number: 0001825034-2025-02307
• Device Sequence Number: 8769460
• Product Code: MBF
• UDI-Device Identifier: 00880304449770
• UDI-Public: (01)00880304449770(17)280410(10)710590
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: 113626
• Device Lot Number: 710590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown