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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Thrombosis (2100); Joint Dislocation (2374); Test Result (2695); No Code Available (3191)

Event Date 08/19/2016

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.Investigation summary.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Corrective action was not indicated.(b)(4).

Event Description

"literature article entitled, ¿outcome of revision arthroplasty for failed metal-on-metal total hip replacements; is there a relation to metal ions?¿ by hafiz j.Iqbal, et al, published by hip international (2016), 6 pages, doi: 10.5301/hipint.5000460, was reviewed.The purpose of this study was to assess the early outcome following revision arthroplasty for 106 failed metal-on-metal (mom) thas due to adverse reaction to metal debris (armd) between 2005-2014.Inclusion criteria were failure of mom thas due to armd and/or an increase in blood metal ions greater than 7 ppb.This study reviews thas from a variety of manufacturers.Armd was confirmed intraoperatively defined as presence of intracapsular inflammation or histological inflammatory markers, gross evidence of corrosion or metal debris on the articulations or stem taper, and/or pericapsular soft tissue necrosis.Implanted depuy products: 31 asr-xl/corail thas, 6 mom pinnacle/corail thas, and 1 mom pinnacle/s-rom thas.Results: with the exception of elevated blood metal ion levels, the authors do not specify complications or revisions by manufacturer.The total number of components revised for armd and/or elevated blood metal ions are as follows: 70 cup and head revisions; 5 liner and head revisions; 6 augment, head, and cup revisions; 2 stem, head, and liner revisions; and 22 revisions of all components.The authors do not provide information to identify revisions by manufactured component.The total number of depuy products associated with revisions or complications is unknown.The patients were revised to unknown components.The following complications are associated with the revised mom thas.Elevated blood metal ions: the mean blood ion levels for asr-xl/corail implants was co 28.4 ppb and cr 17.1 ppb.The mean blood metal ions for non-asr xl mom thas was co 21.4 ppb and cr 13.9 ppb.1 postoperative dvt- treatment unknown.8 dislocations- treatment unknown.3 deep infections-treatment unknown.4 superficial infections-treatment unknown.2 hematoma formations- treatment unknown.2 postoperative unspecified fractures- the locations of the perioperative fractures are unknown.Captured in this complaint: asr-xl cup: implant dislocation, implant bearing wear.Pinnacle cup: no reported product problem.Femoral head: implant bearing wear, implant dislocation.Acetabular liner: implant dislocation, implant bearing wear.Asr-xl femoral augment: no reported product problem, femoral stem: implant corrosion of the taper.S-rom femoral sleeve: no reported product problem.Patient harms: foreign body reaction, elevated blood metal ions, soft tissue necrosis, fracture, joint dislocation, infection, hematoma, dvt, medical device removal, surgical intervention.".

• 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 ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9418275
• MDR Text Key: 185501178
• Report Number: 1818910-2019-118728
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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: 11/13/2019
• 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