MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 XTEND MODECC 145EPI POR SZ1 RT; SHOULDER IMPLANT

Catalog Number	130720113
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Fall (1848); Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
Patient had reverse shoulder arthroplasty on (b)(6) 2024, and subsequently had a fall which resulted in the suture line opening and the wound becoming grossly infected.Patient underwent revision surgery on (b)(6) 2025; required dair and then 1st stage revision due to extent of infection and loosening of components (explantation and washout and then cement spacer).
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 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.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: XTEND MODECC 145EPI POR SZ1 RT
• Common Device Name: SHOULDER IMPLANT
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21149056
• Report Number: 1818910-2025-00800
• Device Sequence Number: 9329966
• Product Code: PHX
• UDI-Device Identifier: 10603295510246
• UDI-Public: (01)10603295510246
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 130720113
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 01/17/2025; 01/29/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 01/20/2025; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNK SHOULDER GLENOSPHERE DELTA XTEND.; UNK SHOULDER HUMERAL CUP DELTA XTEND.; UNK SHOULDER HUMERAL STEM DELTA XTEND.; UNKNOWN SHOULDER LOCKING SCREW.; UNKNOWN SHOULDER LOCKING SCREW.; UNKNOWN SHOULDER METAGLENE.; UNKNOWN SHOULDER NON-LOCKING SCREW.; UNKNOWN SHOULDER NON-LOCKING SCREW.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 110 KG