MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +1; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-310

Device Problem Noise, Audible (3273)

Patient Problem Discomfort (2330)

Event Date 05/18/2023

Event Type  Injury  

Event Description

Patient underwent a tha (pinnacle corail wax/poly) in 2018 and the implants failed, polyethylene fracture + contact of the ceramic head with the metal of the acetabular implant.The patient complained to the surgeon about discomfort when carrying out his daily activities, as his prosthesis was rigid and making noise.The loosening of the polyethylene liner of the acetabular component was diagnosed.During the revision procedure, breakage of the polyethylene ards (anti-rotational devices) was verified, which promoted the loosening and early deformation of the implant in question.The doctor replaced the damaged components and there was no damage to the patient.Doi: (b)(6) 2018.Dor: (b)(6) 2023.Affected side: unknown.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic and x-ray evidence found signs of metal transfer of the acetabular cup on the outer surface of the ceramic head, as a result of a disassociation of the acetabular liner from the cup.Unintended contact between the femoral head and the acetabular cup was observed on the attached x-ray image.The observed condition does not represent a device nonconformance.Based on the observation it is reasonable that noise would be present due to the ceramic head articulating against the metal cup.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.

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.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, ¿patient underwent a tha (pinnacle corail wax/poly) in 2018 and the implants failed, polyethylene fracture + contact of the ceramic head with the metal of the acetabular implant.The patient complained to the surgeon about discomfort when carrying out his daily activities, as his prosthesis was rigid and making noise.The loosening of the polyethylene liner of the acetabular component was diagnosed.During the revision procedure, breakage of the polyethylene ards (anti-rotational devices) was verified, which promoted the loosening and early deformation of the implant in question.The doctor replaced the damaged components and there was no damage to the patient.Note: the invoice is attached, paying attention to the fact that the invoice was issued directly from j&j to the hospital and not by the distributor, however, as the distributor represents j&j, the doctor requested our assistance¿.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample found signs of metal transfer on the outer surface of the delta cer head 12/14 32mm +1, as a result of a disassociation of the acetabular liner from the cup.The observed condition does not represent a device nonconformance.Based on the observation it is reasonable that noise would be present due to the ceramic head articulating against the metal cup.A manufacturing record evaluation was performed for the finished device [136532310 / 8580779] 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 32mm +1 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 [136532310 / 8580779] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: DELTA CER HEAD 12/14 32MM +1
• 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17039543
• MDR Text Key: 316328928
• Report Number: 1818910-2023-11309
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033431
• UDI-Public: 10603295033431
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/01/2023

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
• Device Operator: Health Professional
• Device Model Number: 1365-32-310
• Device Catalogue Number: 136532310
• Device Lot Number: 8580779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 07/19/2023; 09/28/2023; 10/12/2023
• Supplement Dates FDA Received: 07/20/2023; 10/03/2023; 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2017
• 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 32IDX50OD; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female