MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 HUMERAL HEAD 46X16; SHOULDER IMPLANT - HUMERAL HEAD

Catalog Number	520046160
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Fall (1848); Unspecified Tissue Injury (4559)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient fell and tore rc.Doi: (b)(6) 2025.Dor: (b)(6) 2025.Affected side: unknown shoulder.
Additional Manufacturer Narrative
Product complaint: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint recon described in this report.H11 additional narrative: added: h6 health effect clinical code and medical device problem code.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Us fda mdr determination: rotator cuff tear was reported to have occurred as a direct consequence to an external force caused by a fall.The upper extremity is not a weightbearing limb during standing or ambulation, and therefore the implanted device could not have been contributory to the fall.There is no reported product deficiency and therefore the event will not be reported as a serious injury at this time.Original determinations of serious injury were reported in error.

• Brand Name: HUMERAL HEAD 46X16
• Common Device Name: SHOULDER IMPLANT - HUMERAL HEAD
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23772104
• Report Number: 1818910-2025-21614
• Device Sequence Number: 9750559
• Product Code: MBF
• UDI-Device Identifier: 10603295538363
• UDI-Public: (01)10603295538363(17)29131(10)351143
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K202716
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: Health Professional
• Device Catalogue Number: 520046160
• Device Lot Number: 351143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 12/12/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 12/12/2025; 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2025
• 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 Age: 69 YR
• Patient Sex: Female