MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +1; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number	136532310
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that delta cer head 12/14 32mm +1 and pinn mar +4 10d 32idx48od were involved in a reported event.The event concerned premature wear of polyethylene and ceramic materials, leading to two revision surgeries for replacement of the insert and head.The patient required corrective invasive procedures, and the impacted implants were explanted.
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).Investigation summary: according to the information provided: "they request a study of the following surgery performed at the [redacted] on (b)(6) 2021 ¿ [redacted]¿ sergas surgery ¿ order: (b)(4): 121732048 lot: 9683877; 121932148 lot: j93j09; 3l92511 lot: 5375911; 136521000 lot: d210121591.Revision of the insert and head on (b)(6) 2025 in the [redacted]: 121932148 lot: m27n00; 136532310 lot: 4753740.The patient is admitted back to the [redacted] to make another replacement on (b)(6) 2026.They request a study of the following references: -121932148 with lot: m27n00; -136532310 with lot: 4753740; 121732048 with lot: 9683877.Material prepared to be collected in orto-aríns ([redacted]).A.Have any specific claims been made against the notified product? premature wear of polyethylene.B.Was there any harm to the patient/consequence related to the event? two revisions / replacement polyethylene and premature head.C.Were there any surgical delays related to the event? d.Could you provide the name of the account/hospital? [redacted]¿ [redacted] ¿ sergas // [redacted] ¿ [redacted] ¿ sergas.E.Could you provide the date of the event? 1st surgery on (b)(6) 2021 ¿ 2nd surgery on (b)(6) 2025 and 3rd on (b)(6) 2026.Do not include the name of the doctors or centers in the collection request.(in the previous application the courier had all the documentation provided in the email).121932148 with lot: m27n00 -136532310 with lot: 4753740 -121732048 with lot: 9683877: joint reconstruction, affected side: unknown, affected quantity: 1, quantity available for return: 1.List the j&j products that were used during the case but did not contribute to the reported event.121732048 lot: 9683877; 121932148 lot: j93j09; 3l92511 lot: 5375911; 136521000 lot: d210121591.Revision of the insert and head on (b)(6) 2025 in the [redacted]: 121932148 lot: m27n00; 136532310 lot: 4753740".The product was not returned to depuy synthes; however, photos were provided for review.The photographs attached were reviewed, however they do not represent the reported complaint, as photos belong to the 3rd surgery (on (b)(6) 2026).Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.A manufacturing record evaluation was performed for the finished device 4753740 lot number, and one non-conformance was identified, however not related to the reported failure mode of the complaint.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint.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 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 4753740 lot number, and one non-conformance was identified, however not related to the reported failure mode of the complaint.Added: d10 (concomitant), h4.

• Brand Name: DELTA CER HEAD 12/14 32MM +1
• 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): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24615629
• Report Number: 1818910-2026-04878
• Device Sequence Number: 9575774
• Product Code: LZO
• UDI-Device Identifier: 10603295033431
• UDI-Public: (01)10603295033431(17)300228(10)4753740
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K031803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted 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

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: 136532310
• Device Lot Number: 4753740
• 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: 03/01/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2025
• 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: PINN MAR +4 10D 32IDX48OD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown