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

Catalog Number	136528740
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient initially had an hps 2 stem with a stryker cup.Patient was revised back on (b)(6) 2024 due to dislocation.Patient hip was showing signs of infection.Surgeon did a head/liner exchange and thoroughly wash out the wound.Same implants were opened and implanted that were removed.There was no surgical delays or adverse events.Hip was reduced and stability was confirmed.Doi-(b)(6) 2024.Dor- (b)(6) 2024.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 (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).Investigation summary : no device associated with this report was received for examination.A manufacturing record evaluation (nc search) was performed for the finished device product code:136528740, lot:4437058 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 (nc search) was performed for the finished device product code:136528740, lot:4437058 and no non-conformances / manufacturing irregularities were identified.

• Brand Name: DLT TS CER HD 12/14 28MM +12
• 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): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20881911
• Report Number: 1818910-2024-25064
• Device Sequence Number: 18088553
• Product Code: KWA
• UDI-Device Identifier: 10603295033332
• UDI-Public: (01)10603295033332(17)290228(10)4437058
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 136528740
• Device Lot Number: 4437058
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• 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: 83 YR
• Patient Sex: Male