MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136536330

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Erythema (1840); Fever (1858); Hematoma (1884); Unspecified Infection (1930); Pain (1994)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.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.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 Description

Non mom medical records on attachments (b)(4) medical records ad (b)(6) 2023 (1), (b)(4)medical records ad (b)(6) 2023 (1), and (b)(4) medical records ad (b)(6) 2023 (2) were reviewed by a clinician for adverse events.On (b)(6) 2019, the patient underwent a left total hip arthroplasty utilizing a cementless corail stem (product code 3l93173) and ceramic head (136536330) with competitor cup and liner.There were no intraoperative complications.On (b)(6) 2019, the patient is admitted to the hospital for pain, shaking, feeling cold/chilled, clammy with a left incision that was red and swollen.He was transferred to another hospital where an i&d was performed with removal of the left competitor cup/liner and depuy stem and head.He was provided a spacer made of competitor cement and given iv antibiotics via picc line.On (b)(6) 2019, the patient became febrile, hypotensive and tachycardic requiring hospitalization and underwent another revision where the spacer made of competitor cement was removed, a hematoma was evacuated and depuy¿s prostalac was placed.On (b)(6) 2019, the patient undergoes a left hip reimplantation where a competitor cup/liner was placed and depuy stem (l20314) and head (136528330) was placed.Doi: (b)(6) 2019.Dor: (b)(6) 2019.Left hip 1st revision.

• Brand Name: DELTA CER HEAD 12/14 36MM +8.5
• Type of Device: 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18143489
• MDR Text Key: 328199977
• Report Number: 1818910-2023-23335
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033639
• UDI-Public: 10603295033639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 136536330
• Device Lot Number: 9235242
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CORAIL2 LAT COXA VARA SIZE 13; STRYKER; STRYKER; STRYKER; STRYKER; STRYKER; STRYKER
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 100 KG