MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); 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) female implanted with a pinnacle cup, metal liner, cocr femoral head, and corail stem.Revised cup, head, and liner due to armd.Pre-revision symptoms: clunking of the operative hip.Blood metal ions: co 356 ppb cr 255 ppb.Intraoperative findings: soft tissue necrosis, iliopsoas pseudotumor, and periarticular synovial thickening consistent with foreign body reaction.There was no reported product problem with the stem or the cup.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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 ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9453955
• MDR Text Key: 185482353
• Report Number: 1818910-2019-122565
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• 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 ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR