MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 32MM +9; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136532730

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

Patient Problems Wound Dehiscence (1154); Cellulitis (1768); Erythema (1840); Hematoma (1884); Pain (1994); Swelling/ Edema (4577)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer.Component code: appropriate term/code not available (g07002) used to capture no findings available.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.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.

Event Description

This complaint was created in relation to aei note a-8851225 under (b)(4) stated that (b)(4) medical records ad 1 mar 2023 (2), (b)(4) medical records ad 1 mar 2023 (3) were reviewed by clinician.On (b)(6) 2010, the patient had a right total hip arthroplasty to address osteoarthritis.Depuy components were implanted at this time.On (b)(6) 2022, the patient had a right revision to address failed right total hip arthroplasty.It was noted the patient had pain, elevated serum levels of cobalt and chromium, and radiographs showed osteolysis.Depuy metal on metal head/liner were revised to a poly on ceramic construct.Depuy components were implanted during this procedure.(b)(4).On (b)(6) 2022, the patient had a right hip revision to address right hip cellulitis.The postoperative diagnosis included hematoma and fascia/gluteus dehiscence.The patient was experiencing swelling, pain and some redness.The patient was noted to be 6 weeks postop from right revision to ceramic on poly bearing surface.Doi: (b)(6) 2010 - cup, stem and 2 bone screws.Doi: (b)(6) 2022-ceramic head and poly liner.Dor: (b)(6) 2022.Right hip.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : update: 03-oct-2023.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.

Event Description

Medical records received.On (b)(6) 2022, the patient had a right hip revision, culture, irrigation, and debridement to address hematoma, cellulitis, and fascia/gluteus dehiscence.The indications for surgery also included: pain.The liner/head was revised and a wound vac was placed.

• Brand Name: DLT TS CER HD 12/14 32MM +9
• 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16654665
• MDR Text Key: 312409036
• Report Number: 1818910-2023-07014
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2023

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: 136532730
• Device Lot Number: 9611454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 08/24/2023; 10/03/2023
• Supplement Dates FDA Received: 09/21/2023; 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• 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: ALTRX +4 NEUT 32IDX50OD; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE SECTOR II CUP 50MM; SUMMIT POR TAPER SZ4 STD OFF; UNK HIP ACETABULAR LINER POLY; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNK HIP FEMORAL HEAD CERAMIC; UNK HIP FEMORAL STEM SUMMIT; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female