MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS SHL 3HOLE 54; HIP IMPLANT : ACETABULAR CUP

Catalog Number	471054300
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant in the box was a 48mm cup and the box was labeled as 54mm cup.A second 54mm cup was on hand so there was no deviations to the procedure or consequences to the patient.No surgical delay was reported.Affected size: unknown hip.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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: d9.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: it was reported that the implant in the box was a 48mm cup and the box was labeled as 54mm cup.Surgical delay unknown.Photos were provided for review.Furthermore, with the photo evidence provided, a manufacturing investigation was performed by the j&j medtech orthopaedics cork team.The photo evidence was able to confirm the reported event, an incorrect size product was found inside a package that did not match with the labeling content.This product issue has been addressed through the j&j medtech orthopaedics quality management system.Based on the manufacturing investigation it was determined that the reported failure mode can be attributed to j&j medtech orthopaedics cork.Human-error is the assignable cause for this nonconformance.The overall complaint was confirmed as the observed condition of the emsys shl 3hole 54 would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation.This product issue will be addressed through j&j medtech orthopaedics quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: nr was created to address current complaint condition.

• Brand Name: EMSYS SHL 3HOLE 54
• Common Device Name: HIP IMPLANT : ACETABULAR CUP
• 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: 21934129
• Report Number: 1818910-2025-06701
• Device Sequence Number: 17478581
• Product Code: LPH
• UDI-Device Identifier: 10603295500612
• UDI-Public: (01)10603295500612(17)341130(10)4646295
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K221636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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: 471054300
• Device Lot Number: 4646295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 05/01/2025; 06/17/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/06/2025; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2025
• 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
• Patient Age: 68 YR
• Patient Sex: Male