MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 STEMLESS M 36; SHOULDER IMPLANT - HUMERAL HEAD

Catalog Number	520000036
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
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 which 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 reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.H11 additional narrative: added: d10 (concomitant).
Event or Problem Description
Patient was revised due to anatomic head disassociated from stemless component.No additional information.Doi: (b)(6) 2025, dor: (b)(6) 2025, affected side: right shoulder.(b)(4) are related.(b)(4) is created for right shoulder, (b)(4) is created for left shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: d4: udi: as the catalog/model number was not provided, the (01)gtin is not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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 which 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 reconstruction, or its employees caused or contributed to the potential event described in this report.H11.Additional narrative: added: b5, d1, d4 (catalog) (lot) (expiration date), g4(pma/ 510(k), h4.Corrected: d1, d2a, d4 (primary udi number).H6.Health effect - impact code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: can you please confirm if this is left or ride side? it was the patient¿s right shoulder, and the humeral head and taper adapter (as a construct) were disassociated from the stemless implant.The stemless implant was well fixed, so the surgeon left it in and replaced the head and adapter with a new one.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) investigation summary = > according to the information provided: "patient was revised due to anatomic head disassociated from stemless component.No additional information.Doi: (b)(6) 2025.Dor: (b)(6) 2025.Affected side: right shoulder".The product was not returned to depuy synthes for evaluation.Only the taper (anatomic offset taper adapter) and head (humeral head 46x16) were returned for evaluation.Although the stem (stemless m 36) was not returned for evaluation, given the patterns observed on the taper, it is reasonable to consider the device could not be assembled as intended with this mating component, condition that could have led the device assembly to fail/disassociate.However, without concrete evidence or further information, it is not possible to determine a definitive root cause.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing record evaluation was performed for the finished device 663638 lot number, and no non-conformances nor manufacturing irregularities were identified.The overall complaint was confirmed given the patterns observed on the device mating component (anatomic offset taper adapter).The stemless m 36 would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = > a manufacturing record evaluation was performed for the finished device 663638 lot number, and no non-conformances nor manufacturing irregularities were identified.

• Brand Name: STEMLESS M 36
• Common Device Name: SHOULDER IMPLANT - HUMERAL HEAD
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork IN ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23887398
• Report Number: 1818910-2025-22476
• Device Sequence Number: 9463990
• Product Code: MBF
• UDI-Device Identifier: 10603295538257
• UDI-Public: (01)10603295538257(17)291130(10)663638
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K203108
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 520000036
• Device Lot Number: 663638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 02/11/2026; 04/02/2026; 06/17/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/06/2026; 02/12/2026; 04/14/2026; 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ANATOMIC OFFSET TAPER ADAPTER; ANATOMIC OFFSET TAPER ADAPTER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 235 LB