MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 REVERSE HUMERAL SHELL M 36+0; SHOULDER IMPLANT - HUMERAL HEAD

Catalog Number	550000360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
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.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: 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 manufacturing records evaluation (mre) was not performed.
Event or Problem Description
It was reported that a clinical adverse events were received for conjoined tendinitis: device and procedure (relatedness), device related: not related, procedure related: possible, date of event: 05 sep 2025, date of implant: on (b)(6) 2025, date of revision: no information provided, device location: no information provided.Subject id: (b)(6).Study no: (b)(4).Treatment/impact: rehabilitation, injected medication (specify: 2 ml of 1% lidocaine 2 ml of 0.25% marcaine and 2 ml of betamethasone) and oral/topical medication.Depuy synthes product used: catalog number: 520000036, lot number: 662705, component type: humeral, unique device id: (b)(4).Catalog number: 550011240, lot number: 663951, component type: baseplate, unique device id: (b)(4).Catalog number: 550300500, lot number: 229406, component type: screw, unique device id: (b)(4).Catalog number: 550040600, lot number: 206414, component type: screw, unique device id: (b)(4).Catalog number: 550532008, lot number: 347232, component type: glenosphere, unique device id: (b)(4).Catalog number: 550000360, lot number: 664116, component type: shell, unique device id: (b)(4).Catalog number: 550032000, lot number: mi1777, component type: liner, unique device id: (b)(4).
Event or Problem Description
Additional information received: treatment/impact: rehabilitation, injected medication (specify: 2 ml of 1% lidocaine 2 ml of 0.25% marcaine and 2 ml of betamethasone) and oral/topical medication (specify: medrol dosepak), outcome: recovering/resolving.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: REVERSE HUMERAL SHELL M 36+0
• 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: 23286021
• Report Number: 1818910-2025-17515
• Device Sequence Number: 5559384
• Product Code: PHX
• UDI-Device Identifier: 10603295546986
• UDI-Public: (01)10603295546986(17)300430(10)664116
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 550000360
• Device Lot Number: 664116
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White