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

Model Number	1365-40-740
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ecchymosis (1818); Erythema (1840); Fall (1848); Fever (1858); Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021 physical therapy notes stating the left hip demonstrates an effusion and the patient has recently fallen.Physical therapy notes on (b)(6) 2021 state the left hip is very swollen, red, and hard.The patient also states he may have had a low grade fever.The treatment was not completed due to concerns over infection.Notes detail a physical therapy evaluation performed on (b)(6) 2021.The notes state the left hip is bruised with a significant effusion.This pc was created to capture the harm reported post left hip revision on (b)(6) 2021.
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.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 the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DLT TS CER HD 12/14 40MM +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): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16111804
• Report Number: 1818910-2023-00645
• Device Sequence Number: 20247802
• Product Code: KWA
• UDI-Device Identifier: 10603295033721
• UDI-Public: 10603295033721
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2023

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: 09/30/2025
• Device Model Number: 1365-40-740
• Device Catalogue Number: 136540740
• Device Lot Number: 9611583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 03/07/2023; 04/25/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 03/07/2023; 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• 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: ALTRX +4 10D 40IDX60OD.; APEX HOLE ELIM POSITIVE STOP.; PINN CAN BONE SCREW 6.5MMX30MM.; PINN CAN BONE SCREW 6.5MMX35MM.; PINNACLE MULTIHOLE II CUP 60MM.; TRI-LOCK 10.0MM LAT OFFSET.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White