MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 XTEND MODECC 145EPI POR SZ1 LT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	130720112
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Doing a global unite reverse total shoulder (left); stem and epi would not mate.Seems to be a mismatch or machining issue.Another stem and epi were opened and the combination worked as expected.Procedure was completed successfully with a five-minute delay.There was no patient consequence.
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 Manufacturer Narrative
Product complaint #:(b)(4).Investigation summary = > doing a global unite reverse total shoulder, stem and epi would not mate.Seems to be a mismatch or machining issue.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.See attachment re_ urgent replacement request (b)(4).The photographs attached were reviewed, however they do not represent the reported complaint.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.A manufacturing record evaluation was performed for the finished device product description: xtend modecc 145epi por sz1 lt product code: 130720112 lot number: 4582523 and no non-conformances or manufacturing irregularities were identified regarding the complained device issue.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint.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 complaint condition.As part of j&j medtech orthopaedics 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 product description: xtend modecc 145epi por sz1 lt product code: 130720112 lot number: 4582523 and no non-conformances or manufacturing irregularities were identified regarding the complained device issue.Device history review = > a manufacturing record evaluation was performed for the finished device product description: xtend modecc 145epi por sz1 lt product code: 130720112 lot number: 4582523 and no non-conformances or manufacturing irregularities were identified regarding the complained device issue.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, ¿doing a global unite reverse total shoulder, stem and epi would not mate.Seems to be a mismatch or machining issue¿.The reported xtend modecc 145epi por sz1 lt (lot.4582523) and photos of the product labels were returned to depuy synthes for evaluation.The depuy synthes team forwarded all the available evidence to the manufacturing site for further evaluation.Based on the manufacturing investigation, it was confirmed that the tab (assembly feature) width of the global unite std stem sz 10 (lot.4554806) was out of the maximum tolerance limit; this dimensional non-conformance prevents the implant from properly assembling with the mating device.However, there is no indication that the xtend modecc 145epi por sz1 lt contributed to the assembly issue.A manufacturing record evaluation was performed for the finished device product description: xtend modecc 145epi por sz1 lt product code: 130720112 lot number: 4582523 and no non-conformances or manufacturing irregularities were identified regarding the complained device issue.The overall complaint was confirmed based on the available evidence and the returned devices.However, the xtend modecc 145epi por sz1 lt device would not have contributed to the assembly 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 product description: xtend modecc 145epi por sz1 lt product code: 130720112 lot number: 4582523 and no non-conformances or manufacturing irregularities were identified regarding the complained device issue.Device history review a manufacturing record evaluation was performed for the finished device product description: xtend modecc 145epi por sz1 lt product code: 130720112 lot number: 4582523 and no non-conformances or manufacturing irregularities were identified regarding the complained device issue.Added: d9, d10 (concomitant).Corrected: h3.

• Brand Name: XTEND MODECC 145EPI POR SZ1 LT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22116938
• Report Number: 1818910-2025-08795
• Device Sequence Number: 4251125
• Product Code: PHX
• UDI-Device Identifier: 10603295510239
• UDI-Public: (01)10603295510239(17)20340930(10)4582523
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 130720112
• Device Lot Number: 4582523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 07/07/2025; 03/17/2026
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/08/2025; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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: GLOBAL UNITE STD STEM SZ 10
• Patient Sex: Unknown