MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 40MM +8.5; HIP CERAMIC FEMORAL HEAD

Catalog Number	136540730
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the surgeon performed an i&d and wash out of previous hip arthroplasty.The patient had been admitted showing the initial stages of an infection following a primary hip arthroplasty performed the month prior.In order to effectively treat the infection, an open debridement and washout was performed.In order to have good exposure of the surgical site, the modular femoral head (ceramic ts) was removed.A fresh modular femoral head (ceramic ts) was implanted upon completion of the wash out.There are no known patient consequences as a result of this procedure.Doi: (b)(6) 2026.Dor: (b)(6) 2026.Affected side: left 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: b5.Corrected : h6 (health effect - clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: the patient had been admitted showing the initial stages of an infection following a primary hip arthroplasty performed the month prior.In order to effectively treat the infection, an open debridement and washout was performed.In order to have good exposure of the surgical site, the modular femoral head was removed.A fresh modular femoral head was implanted upon completion of the wash out.There are no known patient consequences as a result of this procedure, nor resulting from the functionality/stability/quality of the depuy synthes prosthesis, no further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- no device associated with this report was received for examination.A search of the depuy synthes(nc) quality system found no nc¿s associated with this product code: 136540730, lot - 4662984 combination.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 search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product code: 136540730, lot - 4662984 combination.

• Brand Name: DLT TS CER HD 12/14 40MM +8.5
• Common Device Name: HIP CERAMIC FEMORAL HEAD
• 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: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24641376
• Report Number: 1818910-2026-05020
• Device Sequence Number: 15926449
• Product Code: LZO
• UDI-Device Identifier: 10603295033714
• UDI-Public: (01)10603295033714(17)291231(10)4662984
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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 Catalogue Number: 136540730
• Device Lot Number: 4662984
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 04/06/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 03/23/2026; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male