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	Insufficient Information (4580)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a revision procedure due to pinnacle liner luxation out of the pinnacle cup; one piece has broken off.The head had been articulating against the cup floor and now shows signs of wear.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
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: b5, d10 (concomitant).Corrected: d2a, d2b, d3.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: a.Were the head and/or cup showing signs of wear? - yes, but after the liner had dislocated.
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 recon described in this report.H11 additional narrative: added: d4 (lot, expiration date),d9, h4.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).Follow up (2) of (1818910-2025-20761) was not reported late.The g3.Date received by manufacturer was incorrectly reported and the correct date is 05-01-2026, which makes the report submission due date to be 04-02-2026.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > pinnacle liner which is revised due to luxation out of the pinnacle cup.One piece has broken off.Head [product code removed] has been articulating against the cup floor.(shown in picture attached).The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the delta cer head 12/14 32mm +9 has signs of metal transfer, most likely caused by the head being in contact with the acetabular cup after the disassociation event occurred.However, metal transfer is not indicative of wear on the femoral head.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.A manufacturing record evaluation was performed for the finished device product description: delta cer head 12/14 32mm +9 product code: 136532330 lot number: 3968478 and no non-conformances or manufacturing irregularities were identified.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 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: delta cer head 12/14 32mm +9 product code: 136532330 lot number: 3968478 and no non-conformances or manufacturing irregularities were identified.Device history review = > a manufacturing record evaluation was performed for the finished device product description: delta cer head 12/14 32mm +9 product code: 136532330 lot number: 3968478 and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: h3.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: pinnacle liner which is revised due to luxation out of the pinnacle cup.One piece has broken off.Head [product code removed] has been articulating against the cup floor.(shown in picture attached).The product was not returned to depuy synthes; however, photos were provided for review.See attachment return document attached and pickup booked! - (b)(4).The photo investigation revealed that the delta cer head 12/14 32mm +9 has signs of metal transfer, most likely caused by the head being in contact with the acetabular cup after the disassociation event occurred.However, metal transfer is not indicative of wear on the femoral head.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.A manufacturing record evaluation was performed for the finished device product description: delta cer head 12/14 32mm +9 product code: 136532330 lot number: 3968478 and no non-conformances or manufacturing irregularities were identified.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 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: delta cer head 12/14 32mm +9 product code: 136532330 lot number: 3968478 and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: delta cer head 12/14 32mm +9 product code: 136532330 lot number: 3968478 and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: d4 (primary udi number).

• 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 Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23649285
• Report Number: 1818910-2025-20761
• Device Sequence Number: 20059423
• Product Code: LZO
• UDI-Device Identifier: 10603295033455
• UDI-Public: (01)10603295033455(17)271031(10)3968478
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K031803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,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: 136532330
• Device Lot Number: 3968478
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 11/26/2025; 11/11/2025; 01/08/2026; 01/19/2026; 01/20/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 11/26/2025; 01/06/2026; 01/08/2026; 01/20/2026; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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: PINN MAR NEUT 32IDX52OD.; UNKNOWN HIP ACETABULAR CUP.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown