MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Nonstandard Device (1420); Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fever (1858); Unspecified Infection (1930); Necrosis (1971); Pain (1994); No Code Available (3191)

Event Date 01/01/2006

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

An article ¿acute delayed infection: increased risk in failed metal on metal total hip arthroplasty¿ by hernan a.Et al on retrospective reporting of a series of 124 patients (20 females and 104 males, average age of 51.5 years) with asr implants presenting with acute delayed or late periprosthetic joint infection (pji) as a mode of failure for this particular design between june 2006 and february 2010.Total 143 consecutive metal-on-metal primary thas (124 patients), performed with the depuy asr xl acetabular hip system (112 hips) and depuy asr hip resurfacing system (31 hips).8 male cases were reported with confirmed periprosthetic deep infection, 6 cases with asr xl acetabular system and 2 cases with asr hip resurfacing system.Of those 8 deep pji, 4 cases presented as a delayed acute infection (>3 < 24 months after the index primary hip arthroplasty), and 4 cases presented with a late infection after 24 months.Loosening of cup along with metallosis was reported in one case.Two hips required irrigation and debridement with component retention (1 hip resurfacing arthroplasty and 1 total hip arthroplasty before the recall had occurred), two hips underwent irrigation and debridement with acetabular revision and retention of well-fixed femoral component (after recall occurred) and 4 hips were treated with 2-stage exchange.All the patients are identifiable for reported adverse event.Cup loosening, cup malposition, infection, metallosis, irrigation and debridement, acetabular revision were observed due to depuy asr xl acetabular hip system and depuy asr hip resurfacing system.Case #4 (b)(6) year-old male with asr implantation received revision 5 months post initial implantation.The article clarifies he received only irrigation and debridement during revision and retained all device components(per table 1 page 1810).It is noted that implantation measurements of the cup 50 degrees abduction angle and 30 degrees ante-version angle.Noted are the following patient adverse events: surgery intervention, pain, fever, chills, drainage, redness, infection, necrosis, no explantation of components.Noted are the following product adverse events: malpositioned cup.

Manufacturer Narrative

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.Product complaint #: (b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.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: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up 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 INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 8833481
• MDR Text Key: 152496197
• Report Number: 1818910-2019-99416
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR