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
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.
Event or Problem Description
It was reported that pinn mar +4 10d 32idx48od, delta cer head 12/14 32mm +1, and pinn sector w/gription 48mm were involved in a reported event.The complaint described premature wear of polyethylene and implant bearing materials, resulting in two revision surgeries and replacement of the polyethylene insert and femoral head.The event was associated with implant disassociation between the cup and liner, and the affected implants were explanted and prepared for return.
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: 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).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.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]"¿ (b)(6) 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]" ¿ (b)(6) // "[redacted]" ¿ "[redacted]" ¿ (b)(6).E.Could you provide the date of the event? 1st surgery (b)(6) 2021 ¿ 2nd surgery (b)(6) 2025 and 3rd (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 photo investigation revealed the device with metal transfer on their convex area and signs of being implanted for a period of time.Metal transfer is an indicative of the device coming in contact with the cup as a consequence of a dissociation between the pinn mar +4 10d 32idx48od (liner) and the pinn sector w/gription 48mm (cup).It is important to mention that the metal transfer is not considered a device non-conformance.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 observed condition of the delta cer head 12/14 32mm +1 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 4753740 lot number, and one non-conformance was identified, however not related to the reported failure mode of the complaint.
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]"¿ (b)(6) 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: -(b)(4) with lot: m27n00; -136532310 with lot: 4753740; 121732048 with lot: 9683877.Material prepared to be collected in orto-aríns ("[redacted]").Attached are photos.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]" ¿ (b)(6) // "[redacted]" ¿ "[redacted]" ¿ (b)(6).Could you provide the date of the event? 1st surgery (b)(6) 2021 ¿ 2nd surgery (b)(6) 2025 and 3rd (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: (b)(4) # 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 returned to depuy synthes for evaluation.Visual inspection of the returned device revealed the device with metal transfer on its convex area and signs of being implanted for a period of time.Metal transfer is an indicative of the device coming in contact with the cup as a consequence of a dissociation between the pinn mar +4 10d 32idx48od (liner) and the pinn sector w/gription 48mm (cup).It is important to mention that the metal transfer is not considered a device non-conformance.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.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the delta cer head 12/14 32mm +1 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 4753740 lot number, and one non-conformance was identified, however not related to the reported failure mode of the complaint.Corrected: h3.

• 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 -098
• 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: 24589484
• Report Number: 1818910-2026-04744
• Device Sequence Number: 20249499
• Product Code: LZO
• 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: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 136532310
• Device Lot Number: 4753740
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 03/30/2026; 04/21/2026; 05/25/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/30/2026; 04/01/2026; 04/22/2026; 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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; PINN MAR +4 10D 32IDX48OD.; PINN SECTOR W/GRIPTION 48MM; PINN SECTOR W/GRIPTION 48MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown