MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL

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

Patient Problems Fatigue (1849); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 01/19/2023

Event Type  Injury  

Event Description

Patient reported that on or about 3-4 (2012-2015) years, patient experienced severe hip and back pain.Surgeon identified patient hips as "nearly fused in socket," causing the hip to stretch in the si joint to facilitate walking.On (b)(6) 2019, patient had left hip replaced, again recovery went well and physical therapy was successful.Patient was seeing a surgeon, patient was sent for an mri, a fluid aspiration and had heavy metal numbers for chromium and cobalt drawn.The cobalt & chromium both came back elevated.Cobalt levels of 2.9.With this information, surgeon scheduled a revision of the right hip and on (b)(6) 2022 patient right hip ball and cup were replaced.On (b)(6) 2022, a repeat mri showed a small pocket of fluid gathering around the left hip socket.After much debate and 2 second opinions, patient was scheduled for a replacement of the left hip on (b)(6) 2023.With the damage of the right hip (muscles missing) and the left hip replacement, recovery has been very slow.There is not the strength available to guard the left hip during recovery.On (b)(6) 2023, a cobalt chromium revealed a 2.8 levels.Patient was writing a message if the company offers any compensation for damage done? do you know if the ceramic/titanium ball was the best alternative to prevent further damage or need for repairs? patient was a 63 years old and was told to be likely lose my position at work (i am a clinical coordinator, rn) due to the prolonged time for recovery and the likelihood i will continue to require an assistive device (cane or walker) to ambulate.Prior to the hip popping out of joint i required no device even though the hip was in pain.Patient stated that she was too old to be hired for a new position.Patient currently on a walker, still having difficulty getting up from a chair.She was paying for physical therapy copays at $50/week.Her income has been limited due to short-term disability.Patient do not want to pursue legal actions because she do not have the money or desire, but do feel there should be some type of compensation due to the knowledge of the cobalt/chromium reactions and the damage done.Doi: (b)(6) 2019: dor: (b)(6) 2023; left hip.

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.The initial reporter has been removed for confidentiality/privacy.The initial reporter is the patient.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.

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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP FEMORAL HEAD METAL
• Type of Device: METAL FEMORAL HEAD
• 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: 16467484
• MDR Text Key: 310515823
• Report Number: 1818910-2023-04885
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

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: UNK HIP FEMORAL HEAD METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 03/21/2023
• 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: CANCELLOUS SCREW 6.5MM X 35MM; DEPUY 54 PINNACLE SHELL; DEPUY ALTRX 0 DEG 54/36 MM; DEPUY M-SPEC 36MM +8.5 COCR; DEPUY SUMMIT SIZE 6
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female