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

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 09/10/2016

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 received entitled "five-year follow-up of a prospective randomised trial comparing ceramic-onmetal and metal-on-metal bearing surfaces in total hip arthroplasty".Literature article entitled, ¿five-year follow-up of a prospective randomized trial comparing ceramic-on-metal and metal-on-metal bearing surfaces in total hip arthroplasty¿ published by the journal of bone and joint surgery (2017), vol.99-b, pp.1298-1303 was reviewed for mdr reportability.The primary aim of this independent prospective randomized trial was to compare serum metal ion levels for ceramic-on-metal (com) and metal-on-metal (mom) bearing surfaces in total hip arthroplasty (tha).The implants used in each patient differed only in respect to the type of femoral head (ceramic or metal).Patients were randomized to receive either a com or mom bearing combination.All patients received corail amt cementless, collarless femoral stems (depuy), pinnacle acetabular shells and ultramet co-cr-molybdenum alloy liners (both depuy).Patients were randomly assigned to receive a femoral head made of zirconia toughened alumina ceramic (biolox delta modular head (depuy)) or co-cr-molybdenum (ultramet).The size of the modular femoral head was 36 mm in all but two patients (one in each group, both female) who received 28 mm heads.Of the 83 enrolled patients, 67 were available and eligible for review at five years (31 in the mom group and 36 in the com group.Serum co and cr levels increased in both groups postoperatively, with increases sustained to five years in both groups.These elevated ions remained well below the reportable standard of 7ppb with the exception of one revision in the com group.By five years, there had been two revisions in the com group and one in the mom group.Of the revisions, one (in the com group) was a two-stage revision for infection at 46 months after index tha.The second revision in the com group was a revision of the acetabular component performed at 32 months in a (b)(6) year old female patient with persistent pain, raised levels of serum cr (7.1¿g/l) and co (19.7 ¿g/l) and suboptimal acetabular positioning (inclination 68°, anteversion 30°).At revision, the acetabular component was well fixed, with free fluid around the hip and no visible component damage other than minor taper corrosion.Periarticular fluid was found to have high levels of cobalt and chromium (cr 13.4 ¿g/l, co 26 ¿g/l).The single revision in the mom group was performed at 42 months for osteolysis around the proximal part of the femoral component (with a 3 mm radiolucency in gruen zone 1, and a 2 mm radiolucency in gruen zone 7) coupled with thigh pain.Serum cr and co levels measured 1.3 ¿g/l and 1.23 ¿g/l.Joint aspirates revealed no infection.During the revision surgery the femoral component was found to be well fixed and was left in situ.Five years following the index procedure the osteolysis has increased to 4 mm in zones 1 and 7 without clinical consequences.There were radiolucent lines identified in both the com and mom group, none of those lines were symptomatic or confirmed intraoperatively.This complaint will contain 2 pcs.The additional complaint will detail the patient specifically identified within the text.Products coded for infection were revised.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9111144
• MDR Text Key: 164608817
• Report Number: 1818910-2019-105879
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 09/06/2019

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 HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 11/28/2019
• 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