MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 28MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number	136528330
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Cellulitis (1768); Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Physical Asymmetry (4573)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported voluntary report was received (mw5178947).Patient was on a two step stool, reached down to pick up something on the floor, and immediately heard audible.With each step it was noted the hip was making noise, however, the noise lessened after a week and was heard during specific movements.Patient then experienced jolts and stated in retrospect the audible sounds probably started 4-6 months prior to march 8 clinic appt.Patient scheduled an appointment and x-ray showed a catastrophic failure of left hip prosthesis.Metallosis was noted when surgery was done in 2024.Two revision surgeries were completed: in 2024: left hip revision surgery.Patient experienced significant left hip and left foot pain, walking with a stroller.Headball and liner was replaced.Significant metallosis noted.(2024 second hip revision surgery.Acetabular cup, headball and liner replaced metallosis noted.It was believed that the back side was defective.Patient was walking with a cane/stroller.Orthopedic surgeon sent prosthesis into depuy for review.Patient had chemo and radiation in 2024.Patient also had cellulitis dix of left foot.Currently, there is leg length discrepancy.Walking long distance is difficult and continues to have left foot discomfort.There is significant pain during certain leg movements.Placed on steroid pack with improvement.Ct has been ordered.Surgeon stated he was notified by a former pt (since moved to a different state) - 2 months after my surgery that she also experienced a cup failure of the hip prosthesis with metallosis.She was 5 years postoperatively.The common denominator she and i had was the same size cup.Ref report: mw5178948.(b)(4) are related.(b)(4) was created to capture to 1st hip revision.(b)(4) was created to capture to 2nd hip revision.(b)(4) was created to capture post op complication.(b)(4) was created to capture for another patient.
Additional 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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition; therefore, it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device product description: delta cer head 12/14 28mm +8.5, product code: 136528330 lot number: 9828932, and no non-conformances / manufacturing irregularities were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a manufacturing record evaluation was performed for the finished device product description: delta cer head 12/14 28mm +8.5, product code: 136528330 lot number: 9828932, and no non-conformances / manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: delta cer head 12/14 28mm +8.5, product code: 136528330 lot number: 9828932, and no non-conformances / manufacturing irregularities were identified.Added: d10 (concomitant).

• Brand Name: DELTA CER HEAD 12/14 28MM +8.5
• 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: 23866213
• Report Number: 1818910-2025-22383
• Device Sequence Number: 4438486
• Product Code: LZO
• UDI-Device Identifier: 10603295033295
• UDI-Public: (01)10603295033295(17)260531(10)9828932
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 136528330
• Device Lot Number: 9828932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/07/2026; 02/24/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/09/2026; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2021
• 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: ACTIS COLLARED STD SIZE 3; ALTRX NEUT 28IDX44OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 74 KG