MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 STEMLESS L 40; SHOULDER IMPLANT - HUMERAL ANCHOR

Catalog Number	520000040
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Study no: (b)(4).Clinical adverse event received for "failed left reverse total shoulder arthroplasty with humeral component loosening".Device and procedure (relatedness) relationship to study device: causal relationship no relationship to primary study procedure: probable.Device location: left treatment/impact: surgical intervention for the study shoulder: yes single-stage revision: yes.
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 report, a follow-up report will be filed as appropriate.H11 additional narrative: d4: udi: as the catalog/model number was not provided, the (01)gtin is not available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot 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.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 device lot number is unknown.Therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.H11 additional narrative: added: d4 (catalog).
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: 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
Additional information received: treatment/impact: single-stage revision, components removed (humeral stemless implant: yes, reverse humeral shell: yes, reverse liner: yes) components implanted: stemmed component.Depuy synthes products used: catalog number: 520000040.Lot number: 662039.Component type: humeral.Unique device id: inhance shoulder system stemless large diameter 40mm cementless.
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, d4 (catalog, lot, expiry date, primary udi number), g4 [pma/ 510(k)], h4 corrected: d1, d2a, d2b, d3, 10 (concomitant), h6 (health effect - clinical code, medical device problem code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: STEMLESS L 40
• Common Device Name: SHOULDER IMPLANT - HUMERAL ANCHOR
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork IN ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22344390
• Report Number: 1818910-2025-10746
• Device Sequence Number: 4772105
• Product Code: PKC
• UDI-Device Identifier: 10603295538240
• UDI-Public: (01)10603295538240(17)290430(10)662039
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 520000040
• Device Lot Number: 662039
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 09/10/2025; 09/22/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 06/30/2025; 09/17/2025; 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2024
• 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 6.0X35.; GLENOSPHERE 36+4.; LOCKING SCREW 20.; LOCKING SCREW 25.; LOCKING SCREW 35.; MOD UNITI CONV BASEPLATE S 24.; REVERSE HUMERAL SHELL L 40+0.; UNKNOWN BASEPLATE INHANCE.; UNKNOWN CENTRAL SCREW INHANCE.; UNKNOWN GLENOSPHERE INHANCE.; UNKNOWN KICKSTAND INHANCE.; UNKNOWN LOCKING SCREW INHANCE.; UNKNOWN SHOULDER HUMERAL STEMS.; UNKNOWN UNLOCKING SCREW INHANCE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male