MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 8MM MICRO; PROSTHESIS, SHOULDER

Catalog Number	113608
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat: 110031428 lot: 65854040 +3mm thickness 40mm diameter bearing.Cat: 110030776 lot: 66058178 standard offset 40mm diameter glenosphere.Foreign- new zealand.H6: proposed annex g code: mechanical - stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded 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 patient had a revision procedure one month post-initial implantation due to instability.The stem was implanted too low by the surgeon.No additional patient consequences were reported.
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; g1; g3; g6; h1; h2; h3; h6.The reported event is confirmed based on the gap reported in a third-party review and information provided.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.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: reverse total shoulder arthroplasty with widening of the glenohumeral joint which is of uncertain etiology and clinical significance.Information provided from the surgeon identified that the stem was implanted to low in the humerus, resulting in a large gap between the humeral and glenoid components.Further review determined largest sizes of the humeral tray, glenosphere, and bearing were used.As the surgeon stated, the reported instability was due to the stem being implanted too low in the humerus.As a result, the root cause of the reported event is attributed to use error.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.
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; g1; g3; g6; h1; h2.G3: initial medwatch was submitted with a notification date of may 13, 2025 in g3 and submitted on may 21, 2025; however the correct notification date is apr 2, 2025.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: COMP PRIMARY STEM 8MM MICRO
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 22060667
• Report Number: 0001825034-2025-01472
• Device Sequence Number: 12715870
• Product Code: MBF
• UDI-Device Identifier: 00887868267581
• UDI-Public: (01)00887868267581(17)330110(10)65581557
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 08/29/2025

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
• Device Catalogue Number: 113608
• Device Lot Number: 65581557
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 07/24/2025; 04/02/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 08/22/2025; 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 100 KG