MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ARTICULEZE HD CER 40 -2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	473440920
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
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: 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
It was reported that surgeon attempted to implant the new ceramic 40 head size minus 2.The surgeon could not get the head to stick on the trunion of the actis stem.Surgeon tried multiple times with varying degrees of striking pressure.Surgeon ended up implanting a size40 +1.5 head and it stuck fine.Hip was stable.Femoral head was loose.Loosening interface is not applicable and cement manufacturer is unknown.Doe: (b)(6) 2025.Affected side: right hip.
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, 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: it was reported that surgeon attempted to implant the new ceramic 40 head size minus 2.The surgeon could not get the head to stick on the trunion of the actis stem.Surgeon tried multiple times with varying degrees of striking pressure.Surgeon ended up implanting a size40 +1.5 head and it stuck fine.Hip was stable.Femoral head was loose.Loosening interface is not applicable and cement manufacturer is unknown.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the retuned device found that the articuleze hd cer 40 -2 was severely damaged at the taper section, most probably caused by the implantation attempts.The observed condition could be consisted with use of excessive forces while implantation attempts, of axis impactions and heavy usage.Properly handling and attention to the approved use of the device diminishes the risk of failure.Evidence indicates that the device had been properly measured and inspected at the manufacturer through a 100% inspection process.All relevant dimensional checks and specifications were found to be within acceptable limits at the time of release.Consequently, there is no indication of any manufacturing error that could have contributed to the reported issue.A functional test was not performed since mating device was not returned for evaluation.However, the reported condition can be confirmed as a difficulty on the assemblance was most likely caused as a consequence of the observed damage.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A manufacturing record evaluation was performed for the finished device product description: articuleze hd cer 40 -2 product code: 473440920 lot number: 10366b and no non-conformances or manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the articuleze hd cer 40 -2 would have 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 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 record evaluation was performed for the finished device product description: articuleze hd cer 40 -2 product code: 473440920 lot number: 10366b and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: articuleze hd cer 40 -2 product code: 473440920 lot number: 10366b and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: h3.

• Brand Name: ARTICULEZE HD CER 40 -2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• 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: 22630620
• Report Number: 1818910-2025-13019
• Device Sequence Number: 7990163
• Product Code: LZO
• UDI-Device Identifier: 10603295505747
• UDI-Public: (01)10603295505747(17)341231(10)10366B
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K222296
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 473440920
• Device Lot Number: 10366B
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 07/28/2025; 09/05/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 07/29/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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: ARTICULEZE HD CER 40 -2.
• Patient Age: 70 YR
• Patient Sex: Female