MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS SHL 3HOLE 48; HIP IMPLANT : ACETABULAR CUP

Catalog Number	471048300
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Wrong Label (4073)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon asked for a 48 emphasys shell and the implant inside contained a 54 emphasys shell.Box and stickers inside the box were labelled 48 mm.It was not implanted.Surgical delay was unknown.Doe: unknown affected side: unknown hip.
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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that 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 that was not available for the initial report is obtained, a follow-up report 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, d10.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: according to the information provided: "it was reported that the surgeon asked for a 48 emphasys shell and the implant inside contained a 54 emphasys shell.Box and stickers inside the box were labelled 48 mm.It was not implanted.Surgical delay was unknown.Doe: unknown affected side: unknown hip".Photos were provided for review.See (re (b)(4) possible mix).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 orthopedic 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 48 would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.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: this product issue has been addressed through the j&j medtech orthopedic quality management system.

• Brand Name: EMSYS SHL 3HOLE 48
• 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: 21764329
• Report Number: 1818910-2025-05072
• Device Sequence Number: 15598984
• Product Code: LPH
• UDI-Device Identifier: 10603295500582
• UDI-Public: (01)10603295500582(17)20341130(10)4645830
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 471048300
• Device Lot Number: 4645830
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 05/01/2025; 06/17/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/16/2025; 05/16/2025; 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
• Concomitant Medical Products and Therapy/Usage Dates: EMSYS SHL 3HOLE 48
• Patient Age: 76 YR
• Patient Sex: Female