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	Naturally Worn (2988)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	08/07/2025
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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient had a primary left thr done in two years ago.Patient with high bmi.The x-ray showed an abnormal position of the implant.She was revisited yesterday (b)(6) 2025.Patient was revised from a 32/50 marathon +4 10 deg liner to a 28/50 marathon lipped liner.The ceramic head was changed from 32 +5 to 28 +12 delta ts head.No surgical delay.Several specimens were collected during surgery, including one of them was for metallosis.
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 hat 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 and d10.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: patient had a primary left thr done in two years ago.Patient with high bmi.The x-ray showed an abnormal position of the implant.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 presents signs of what appears to be metal transfer at the convex surface, most likely by the femoral head being in contact with the acetabular cup after the fractured event occurred.It is worth mentioning that the material transfer is not indicative of a device non-conformance.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 overall complaint was not confirmed as the observed condition of the delta cer head 12/14 32mm +5 would have not contributed to the complained 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: 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.Added: d4 (lot, expiration), h4.Corrected: d4 (primary udi #), h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: patient had a primary left thr done in two years ago.Patient with high bmi.The x-ray showed an abnormal position of the implant.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment (b)(4)- pei complaint.The photo investigation revealed that the delta cer head 12/14 32mm +5 was covered with blood remnants and presents signs of what appears to be metal transfer at the convex surface, most likely by the femoral head being in contact with the acetabular cup after the fractured event occurred.It is worth mentioning that the material transfer is not indicative of a device non-conformance.A manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.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 +5 would have not contributed to the complained 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: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: patient had a primary left thr done in two years ago.Patient with high bmi.The x-ray showed an abnormal position of the implant.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.(b)(4) - pei complaint.The photo investigation revealed that the delta cer head 12/14 32mm +5 was covered with blood remnants and presents signs of what appears to be metal transfer at the convex surface, most likely by the femoral head being in contact with the acetabular cup after the fractured event occurred.It is worth mentioning that the material transfer is not indicative of a device non-conformance.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 +5 would have not contributed to the complained 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: 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.

• 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: 22877545
• Report Number: 1818910-2025-14703
• Device Sequence Number: 10371552
• Product Code: LZO
• UDI-Device Identifier: 10603295033448
• UDI-Public: (01)10603295033448(17)281231(10)4370147
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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
• 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: 136532320
• Device Lot Number: 4370147
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 09/01/2025; 10/28/2025; 11/05/2025; 11/05/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/02/2025; 10/29/2025; 11/06/2025; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2024
• 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 32IDX50OD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female