MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 INHANCE; SHOULDER IMPLANT - HUMERAL ANCHOR

Catalog Number	520000036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Loss of Range of Motion (2032)
Date of Event	02/04/2026
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 (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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Subject id: (b)(6) study no: (b)(6).Clinical adverse event received for poor active motion, possible axillary nerve injury device and procedure (relatedness) device related: not related procedure related: possible date of event: 4 feb 2026 date of implant: (b)(6) 2026 date of revision: no intervention provided device location: right.Treatment/impact: diagnostic intervention: yes specify: ncv/emg.Depuy synthes products used: catalog number: 550036100 lot number: mi191184 component type: liner unique device id: (b)(4).Catalog number: 550310015 lot number: 230230 component type: screw unique device id: (b)(4).Catalog number: 550000360 lot number: 661634 component type: shell unique device id: (b)(4).Catalog number: 550536104 lot number: 351208 component type: glenosphere unique device id: (b)(4).Catalog number: 520000036 lot number: 662988 component type: humeral unique device id: (b)(4).Catalog number: 550310030 lot number: 239924 component type: screw unique device id: (b)(4).Catalog number: 550310020 lot number: 219917 component type: screw unique device id: (b)(4).Catalog number: 550025600 lot number: 234397 component type: screw unique device id: (b)(4).Catalog number: 550011240 lot number: 665007 component type: baseplate unique device id: (b)(4).
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: there is no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Added : d10 concomitant.

• Brand Name: INHANCE
• Common Device Name: SHOULDER IMPLANT - HUMERAL ANCHOR
• 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: 25325095
• Report Number: 1818910-2026-09362
• Device Sequence Number: 5280522
• Product Code: PKC
• UDI-Device Identifier: 10603295538257
• UDI-Public: (01)10603295538257(17)290630(10)662988
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 520000036
• Device Lot Number: 662988
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2024
• 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: CENTRAL SCREW 6.0X25; GLENOSPHERE 36+4 E; LOCKING SCREW 15; LOCKING SCREW 20; LOCKING SCREW 30; MOD UNITI CONV BASEPLATE S 24; REVERSE HUMERAL SHELL M 36+0; REVERSE LINER 36+0 R
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White