MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML-A TOTAL HIP BALL 28MM +5; AML IMPLANT : HIP METAL FEMORAL HEADS

Catalog Number	134567000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown date, the patient underwent primary surgery with the product in question.The surgery was completed successfully without any surgical delay.On (b)(6) 2026, the patient was found to have a confirmed infection.On (b)(6) 2026, the hospital elected to replace the liner and femoral head, while the stem and cup remained in situ due to the absence of looseness.The replacement procedure was completed without surgical delay or complications.No further information is available.
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.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).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: d10, h4.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 no device associated with this report was received for examination.According to the information received, ¿it was reported that on an unknown date, the patient underwent primary surgery with the product in question.The surgery was completed successfully without any surgical delay.On (b)(6) 2026, the hospital found that the patient implanted with duraloc has a possible infection.On (b)(6) 2026, the hospital decided to change the liner and head.On jan 21, there was no looseness in the stem and cup, but the liner and head were replaced considering the infection status.And the replacement was completed smoothly.No further information is available.¿ product description:- aml-a total hip ball 28mm +5 product code:- 134567000 lot no:- 2264784 quantity of manufactured:- (b)(4) date of manufacturing:- 11/02/2006 expiry date:- 11/01/2011 ifu reference:- 78404002.A manufacturing record evaluation was performed for the finished device product description: aml-a total hip ball 28mm +5 product code: 134567000 lot no: 2264784, 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 1) quantity manufactured: (b)(4) 2) date of manufacture: 11/02/2006 3) any anomalies or deviations identified in dhr: none.4) expiry date: 11/01/2011 5) ifu reference: 78404002.Device history review a manufacturing record evaluation was performed for the finished device product description: aml-a total hip ball 28mm +5 product code: 134567000 lot no: 2264784, and no non-conformances / manufacturing irregularities were identified.Corrected: h4.

• Brand Name: AML-A TOTAL HIP BALL 28MM +5
• Common Device Name: AML IMPLANT : HIP METAL 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 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24248021
• Report Number: 1818910-2026-02317
• Device Sequence Number: 9593495
• Product Code: JDI
• UDI-Device Identifier: 10603295021537
• UDI-Public: (01)10603295021537(17)111101(10)2264784
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2011
• Device Catalogue Number: 134567000
• Device Lot Number: 2264784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 02/04/2026; 04/08/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/05/2026; 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2006
• 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: DURALOC 1200 SERIES 48MM OD.; UNKNOWN HIP ACETABULAR LINERS.; UNKNOWN HIP IMPLANT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown