MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number	136532320
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
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
Patient underwent right thr eighteen months prior.Procedure was completed with no problems.The patient had to be revised due to nine month history of clunking/subluxation and six day history of squeaking.X-ray showed liner dissociation.Intraoperatively, the liner spun inferiorly with head articulating with shell.
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 reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added : d9.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).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).Corrected: d4 (primary udi number).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: the implant had ti be revised yesterday (b)(6) 2025 due to the below (please see surgeons explanation below).I have also attached the product details and a picture.From surgeon: right thr 18 months ago.No problems.9 month history of clunking/subluxation.6 day history of squeaking and x ray showed liner dissociation.Intraop liner spun inferiorly with head articulating with shell.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.The photo investigation revealed that the delta cer head 12/14 32mm +5 appears to have signs of material transfer, most likely caused by the head being in contact with the acetabular cup after the disassociation event occurred.However, material transfer is not indicative of a device non-conformance.The observed disassociation could have contributed to the hip joint noise.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 review of the provided evidence confirmed the reported implant noise event involving the delta cer head 12/14 32mm +5.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the implant had ti be revised yesterday (b)(6) 2025 due to the below (please see surgeons explanation below).I have also attached the product details and a picture.From surgeon: right thr 18 months ago.No problems.9 month history of clunking/subluxation.6 day history of squeaking and x ray showed liner dissociation.Intraop liner spun inferiorly with head articulating with shell.¿the product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment (b)(4) (b)(6) hospital.The photo investigation revealed that the delta cer head 12/14 32mm +5 appears to have signs of material transfer, most likely caused by the head being in contact with the acetabular cup after the disassociation event occurred.However, material transfer is not indicative of a device non-conformance.The observed disassociation could have contributed to the hip joint noise.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 review of the provided evidence confirmed the reported implant noise event involving the delta cer head 12/14 32mm +5.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- the implant had ti be revised yesterday 24/07/25 due to the below (please see surgeons explanation below).I have also attached the product details and a picture.From surgeon: right thr 18 months ago.No problems.9 month history of clunking/subluxation.6 day history of squeaking and x ray showed liner dissociation.Intraop liner spun inferiorly with head articulating with shell.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device found that the delta cer head 12/14 32mm +5 shows signs of metal transfer on the outer surface, most likely caused by the head being in contact with the acetabular cup after the disassociation event occurred.However, material transfer is not indicative of a device non-conformance.The observed disassociation could have contributed to the hip joint noise.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 review of the provided evidence confirmed the reported implant noise event involving the delta cer head 12/14 32mm +5.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- the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: h3.

• Brand Name: DELTA CER HEAD 12/14 32MM +5
• 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: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22749285
• Report Number: 1818910-2025-13900
• Device Sequence Number: 9672844
• Product Code: LZO
• UDI-Device Identifier: 10603295033448
• UDI-Public: (01)10603295033448(17)280930(10)4275065
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K031803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 136532320
• Device Lot Number: 4275065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 08/18/2025; 08/19/2025; 08/27/2025; 08/28/2025; 09/22/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/19/2025; 08/21/2025; 08/28/2025; 09/02/2025; 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• 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 NEUT 32IDX50OD.; APEX HOLE ELIM POSITIVE STOP.; CORAIL AMT COLLAR SIZE 14.; PINNACLE 100 ACET CUP 50MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown