MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EMPHASYS; HIP IMPLANT : ACETABULAR LINER

Catalog Number	472256036
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported the emphasys liner would not seat into the acetabular cup during the procedure on (b)(6) 2025.A 10 minute surgical delay was noted.No reported patient harm.
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: d6a, 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: according to the information received, ¿the emphasys liner would not seat into the acetabular cup.¿.The reported emsys lnr aox n 56-58x36 (lot.4876853) was 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, a nonconformance was not confirmed in the emsys lnr aox n 56-58x36 (4876853) reported.The part is compliant with specifications, and the geometric features required for mating with the acetabular cup passed inspection.All inspection results are well within specification limits.A manufacturing record evaluation was performed for the finished device product description: emsys lnr aox n 56-58x36 product code: 472256036, lot number: 4876853, and no non-conformances or manufacturing irregularities were identified regarding the complained device issue.The overall complaint was not confirmed based on the available evidence and returned device.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: emsys lnr aox n 56-58x36 product code: 472256036, lot number: 4876853 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: emsys lnr aox n 56-58x36 product code: 472256036 lot number: 4876853 and no non-conformances or manufacturing irregularities were identified regarding the complained device issue.Corrected: d1, h3.

• Brand Name: EMPHASYS
• Common Device Name: HIP IMPLANT : ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 23789317
• Report Number: 1818910-2025-21733
• Device Sequence Number: 10453138
• Product Code: LPH
• UDI-Device Identifier: 10603295500407
• UDI-Public: (01)10603295500407(17)300630(10)4876853
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 472256036
• Device Lot Number: 4876853
• 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: 11/23/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 03/25/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/08/2026; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2025
• 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 Sex: Unknown