MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 28MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136528310

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 09/02/2023

Event Type  Injury  

Event Description

The patient presented pain and instability of the operated hip, which is why an x-ray was taken that showed displacement of the implants.Additional surgery was required to remove the implants and replace them with others.Doi: (b)(6) 2023; doe: (b)(6) 2023; affected side: unknown.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary = according to the information received, ¿failure of implanted material in hip¿.The product was not returned to depuy synthes, however photos and a radiograph were provided for review.See attachment"source file - fw reporte falla de material".Review of the photographic evidence found signs of metal transfer on the outer surface of the ceramic head, as a result of a disassociation of the acetabular liner from the cup.The observed condition does not represent a device nonconformance.A manufacturing record evaluation was performed for the finished device [136528310 / 9828792] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the delta cer head 12/14 28mm +1.5 would contribute 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 [136528310 / 9828792] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, ¿failure of implanted material in hip¿.The product was not returned to depuy synthes, however photos and a radiograph were provided for review.See attachment"source file - fw reporte falla de material".Review of the photographic evidence found signs of metal transfer on the outer surface of the ceramic head, as a result of a disassociation of the acetabular liner from the cup.The observed condition does not represent a device nonconformance.A manufacturing record evaluation was performed for the finished device [136528310 / 9828792] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the delta cer head 12/14 28mm +1.5 would contribute 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 [136528310 / 9828792] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, ¿failure of implanted material in hip¿.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that delta cer head 12/14 28mm +1.5 presents 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.The observed condition does not represent a device nonconformance, no evidence of wear were observed on the surface of the returned delta cer head 12/14 28mm +1.5.A manufacturing record evaluation was performed for the finished device [136528310 / 9828792] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was not confirmed as the observed condition of the delta cer head 12/14 28mm +1.5 would not contribute 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 [136528310 / 9828792] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: DELTA CER HEAD 12/14 28MM +1.5
• Type of Device: 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17787968
• MDR Text Key: 323913160
• Report Number: 1818910-2023-19221
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 136528310
• Device Lot Number: 9828792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PINN MAR +4 10D 28IDX44OD.; UNKNOWN HIP ACETABULAR CUP.
• Patient Outcome(s): Required Intervention