MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DUR MAR NEUT LINER 28IDX52OD; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number	122028052
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that patient underwent a right hip procedure on (b)(6) 2025.The wrong size locking ring was packed.Another locking ring was used.Procedure was completed successfully with a delay of fifteen minutes.There was no patient consequences.
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 (concomitant).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 wrong locking ring was packed the product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed that an incorrect locking ring was found within a dur mar neut liner 28idx52od.No other defects were observed.According to the investigation conducted by the manufacturer, the reported issue was confirmed to be a manufacturing-related problem attributable to human factors.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.The overall complaint was confirmed as the observed condition of the dur mar neut liner 28idx52od 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 the product issue will be addressed through j&j medtech orthopaedics quality system.An nr and capa have been created to address the reported issue.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: wrong locking ring was packed.The product was returned to j&j medtech orthopaedics for evaluation.Additionally, the available evidence was forwarded to the manufacturing site for further evaluation.Visual inspection of the returned device revealed that an incorrect locking ring was found within a dur mar neut liner 28idx52od.No other defects were observed.According to the investigation conducted by the manufacturer, the reported issue was confirmed to be a manufacturing-related problem attributable to human factors.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the dur mar neut liner 28idx52od 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: the product issue will be addressed through j&j medtech orthopaedics quality system.An nr and capa have been created to address the reported issue.

• Brand Name: DUR MAR NEUT LINER 28IDX52OD
• Common Device Name: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22126468
• Report Number: 1818910-2025-08904
• Device Sequence Number: 7484507
• Product Code: LPH
• UDI-Device Identifier: 10603295015079
• UDI-Public: (01)10603295015079(17)20300619(10)4770642
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K994415
• 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,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: 122028052
• Device Lot Number: 4770642
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 07/29/2025; 08/06/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/18/2025; 07/30/2025; 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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: UNK HIP LOCKING RING.
• Patient Sex: Unknown