MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 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); Sepsis (2067); No Code Available (3191)

Event Date 08/27/2009

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

Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement a consequence of excess wear by d.J.Langton, s.S.Jameson, t.J.Joyce, n.J.Hallab, s.Natu, and a.V.F.Nargol published by the journal of bone & joint surgery on (b)(6) 2009.The article's purpose: "we sought to establish the rate of failure secondary to adverse reactions to metal debris (armd) in our patients, to identify relationships between this mode of failure and the wear rate of the prosthetic joint, and to provide a potential explanation for the increased incidence of this in women.For the purposes of this paper we therefore use the acronym ¿armd¿ as an umbrella term to describe joint failures associated with pain, a large sterile effusion of the hip and/or macroscopic necrosis/metallosis." the study was of 505 asr devices (87 of those were thrs) and 155 bhrs from 2002 to 2009(bhrs were from 2002 to april 2004 and asr was used there after).Table iii lists 17 cases of revision with patient identifiers captured in linked complaints listing descriptive findings of armd.Additionally, table iv included data from other asr revision cases without patient identifiers with reasons of revision as pain, effusion, pseudotumor and fracture (anatomical location not given).It is noted that chromium levels were in the range of 3.89 to 41.8 and cobalt 7.82 to 99.1 for the patients in this study.For histopathological examination of tissues from revision procedures of the 17 identifiable cases: "the various layers of the neo-capsule were studied.Layer 1 consists of the surface membrane and was graded as type 1 to 4.17 type 1 surfaces have an intact pseudosynovial membrane.Type 2 surfaces show a loss of the pseudosynovial membrane.Type 3 surfaces are associated with fibrin deposition in addition to the loss of the surface membrane, and in type 4 there is gross disruption of the surface membrane with fibrin deposition and fissuring.Layer 2 is the subsynovial layer, which usually contains the inflammatory infiltrate.Layer 3 is the vascular layer, which contains the perivascular lymphocytic cuffing.Layer 4 is the deeper layers containing muscle fat and fibrous tissue.The thickness of the histiocyte band containing particulate matter in layer 2 was measured using the graticule.The presence of perivascular lymphocytic cuffing and its average thickness in layer 3 was also recorded." impacted products: asr & asr xl.Adverse events: surgical intervention, foreign body reaction, soft tissue necrosis, pain, hypersensitivity, blood heavy metal increased.

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: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa 00780 superseded by mdd capa-001226.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 rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8975521
• MDR Text Key: 161527992
• Report Number: 1818910-2019-103485
• 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: foreign,literature
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

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
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention