MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +9; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number	136532330
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Liner breakage post-op and head wear.It was reported the patient underwent total hip replacement on (b)(6) 2023.The patient felt left hip pain on (b)(6) 2024 and ct check showed liner breakage and head wear.Then, the second procedure was performed on (b)(6) 2024, the liner and head were replaced by the product with same code.The patient is in a good condition now.
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.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 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.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
Additional information received states that there was no patient consequence and no surgical delay.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: liner breakage post-op & head wear.It was reported the patient underwent total hip replacement on (b)(6) 2023.The patient felt left hip pain on (b)(6) 2024 and ct check showed liner breakage and head wear.Then, the second procedure was performed on (b)(6) 2024, the liner and head were replaced by the product with same code.The patient is in a good condition now.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.See attachment ((b)(4)).Visual inspection of the provided x-ray revealed the femoral head was directly interacting with the acetabular cup, indicating disassociation between liner and acetabular cup.Inspection of the photo revealed material transfer on the surface of the ceramic head, however, this is not indicative of implant bear and wear.The investigation was not able to confirm the reported event.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 not confirmed as the observed condition of the delta cer head 12/14 32mm +9 would have not contributed to the complained device 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 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 = > 1) quantity manufactured: (b)(4).2) date of manufacture: 11/09/2022.3) any anomalies or deviations identified in dhr: none.4) expiry date: 10/31/2027.5) ifu-0902-00-701.

• Brand Name: DELTA CER HEAD 12/14 32MM +9
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 20533640
• Report Number: 1818910-2024-22265
• Device Sequence Number: 6697176
• Product Code: LZO
• UDI-Device Identifier: 10603295033455
• UDI-Public: (01)10603295033455(17)271031(10)3968462
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 10/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 136532330
• Device Lot Number: 3968462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 11/18/2024; 02/14/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/23/2024; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2022
• 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: ALTRX +4 10D 32IDX50OD; DELTA CER HEAD 12/14 32MM +9
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Unknown