MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Necrosis (1971); Test Result (2695); No Code Available (3191)

Event Date 08/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

"literature article entitled, ¿601 metal-on-metal total hip replacements with 36 mm heads a 5 minimum year follow up: levels of armd remain low despite a comprehensive screening program¿ by amit atrey, et al, published by journal of orthopaedics (2017), vol.14, pp.108-114, was reviewed.The purpose of this article is a retrospective study to assess the clinical outcome, failure rate, and reason for failure of a large consecutive series of 36 mm mom corail/pinnacle total hip replacements (thrs).Implanted depuy products: pinnacle cup, metal liner, cocr femoral head, and corail stem.Results: 100 patients had elevated blood metal ions greater than 7 ppb.The mean cobalt level was 120 ppb and chromium level was 135 ppb.These patients were given additional screening with ultrasound and aspirate of the periarticular joint fluid.12 of these patients were revised and captured in case 1-case 2.There were incidences of elevated blood metal ions in the revisions for dislocation, infection, and loosening.6 head and liner revisions due to dislocation.4 revisions due to infection.The components revised were unspecified.1 patient requested revision due to elevated blood metal ions.2 stem and head revisions due to limb asymmetry.4 revisions due to aseptic loosening of either the cup or head.Captured in pc-000600950: pinnacle cup: implant loosening.Acetabular liner: implant dislocation.Femoral head: implant dislocation.Corail stem: implant loosening.Patient harms: surgical intervention, medical device removal, elevated blood metal ions, joint dislocation, inadequate osseointegration, limb asymmetry, infection.This article provides detailed information for 12 patients who were revised due to armd as evidences by elevated blood metal ions, histological confirmation of armd using hip aspirate, or ultrasound evidence of pseudotumor/pseudocapsule.These patients are captured in the attached guidance document labeled case 1-case 12.The parent pc-000600950 captures the revisions and results not identified by patient." (b)(6) male implanted with a pinnacle cup, metal liner, cocr femoral head, and corail stem.Revised cup, head, and liner due to armd.Ultrasound findings: cystic mass.Blood metal ions: co 14 ppb cr 5 ppb.Intraoperative findings: soft tissue necrosis, and periarticular synovial thickening and cyst consistent with foreign body reaction.There was no reported product problem with the stem or the cup.

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

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9454033
• MDR Text Key: 185486173
• Report Number: 1818910-2019-122575
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR