MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM; HIP IMPLANT

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Tinnitus (2103); Metal Related Pathology (4530)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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

(b)(6) 2022.Patient initiated complaint: i have had 2 hip replacement surgeries in the past and have experienced growing amounts of chromium and cobalt in my blood, as well as tinnitus symptoms over the past few years.My right hip was replaced in october of 2004 and my left hip was in january of 2005.Both hip surgeries were tremendously successful and after rehabilitation i was able to resume many activities that were causing pain previously.About 10 years ago i started experiencing mild tinnitus symptoms and went to an ent specialist.Since then, over the past 5 years i have visited with 3 separate audiology offices and undergone hearing tests and consultations looking to find the cause and possible correction to the problem.The first two offices immediately wanted to prescribe hearing aids as solutions to experience better hearing.Nobody has been able to diagnose why or where the problem might have come from.I recently saw on an online search that elevated levels of cobalt in the blood might be a cause of tinnitus.My own cobalt levels have grown from 13 to 25ug/l.It looks like normal range is less than 1ug/l.I have also seen articles on various solutions/procedures that may lower the blood metals (chromium & cobalt) either through the use of medication / or dialysis.Mostly i am just looking for answers to the increasing amounts of ringing in my ears/head.Please let me know if you have any experience with this problem and any direction for improvement.Thank you.

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).D4: the device catalog number is unknown; therefore, udi is unavailable.

Manufacturer Narrative

Product complaint # (b)(4).This medwatch report was initially submitted on 9/22/2022.This report is being resubmitted as this report failed submission as a result of the electronic gateway.Please reference fda ticket csh-28330 for additional details investigation summary, no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot, a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP IMPLANT
• 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: 15401226
• MDR Text Key: 299670473
• Report Number: 1818910-2022-17625
• Device Sequence Number: 1
• Product Code: JWH
• 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,Followup,Followup
• Report Date: 09/22/2022

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 STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 09/12/2022; 09/09/2022; 09/22/2022
• Supplement Dates FDA Received: 09/12/2022; 09/22/2022; 12/02/2022
• 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: UNKNOWN HIP ACETABULAR LINERS.; UNKNOWN HIP FEMORAL HEAD.
• Patient Outcome(s): Required Intervention