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

Device Problem Naturally Worn (2988)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 11/08/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article entitled "results of metal-on-metal hip resurfacing in patients 40 years old and younger" by aleksi reito, antti eskelinen, timo puolakka, jorma pajama¨ki published online 08 november 2012 byarch orthop trauma surg (2013) 133:267¿273 doi 10.1007/s00402-012-1640-2 was reviewed for mdr reportability.Article purpose: "the primary aim of our study was to determine the survivorship of mmhr in patients aged 40 years or less.Our second aim was to analyse activity and quality of life after mmhr in this patient population, likewise the prevalence of comorbid situations and their influence on clinical outcome." the article includes implants: "between may 2001 and may 2008 a total of 1,092 hip resurfacing arthroplasties were performed on 931 patients in our institution.Of these operations, 75 were performed on 64 patients aged under 40 at the time of the primary operation.The indications for arthroplasty were severe pain and/or considerable difficulty with walking and performing daily activities.Four hips in four patients had been revised before the data collection and no patient had died.The remaining 60 patients were asked to participate in this follow-up study.Of the patients, 51 (85 %, 60 hips) agreed to do so by returning the signed informed consent form.Nine patients declined, giving lack of interest as their reason for not participating.None of the patients who refused had undergone revision.The mean followup time was 6.0 years (range 3.0¿7.6).To date six hips (six patients) with asr implants and two hips with bhr implants have been revised and seven of these reoperations were performed due to an adverse reaction to metal debris (armed) in all seven revised patients, a diagnosis of armed was confirmed in revision.The pseudotumor was resected and both prosthetic components were changed to a cementless thr with ceramic-on-ceramic articulation one male patient (one hip) with 51/58 mm asr components was operated on again due to severe heterotopic ossification.Table 3 provides detailed information for each case associated with depuy asr entailing 5 of the 7 revision cases.Case 1 (b)(6) yo female diagnosed with scpe with asr implant, abduction angle 38 degrees with 6.1 years time to revision suffering from painless, neck thining over 10%, co 17 mcg/l and cr 19 mcg/l; operative findings: metal stained joint fluid, green-bluish synovia, bone cyst in the neck.

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.H10 additional narrative: product complaint # (b)(4).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.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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; warsaw; leeds IN LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8952816
• MDR Text Key: 161014972
• Report Number: 1818910-2019-102806
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 09/11/2019
• Supplement Dates FDA Received: 09/11/2019
• 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