MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 49; HIP FEMORAL HEAD

Catalog Number 999890149

Device Problem Noise, Audible (3273)

Patient Problems Dyspnea (1816); Fatigue (1849); Foreign Body Reaction (1868); Granuloma (1876); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Weakness (2145); Injury (2348); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 09/08/2019

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.

Event Description

The patient reports that the procedure and the rehabilitation was successful.(b)(6) 2007: lumbar pain appeared.In 2008: hip pain appeared with abnormal noises which resonated throughout the leg.The analyses was revealed at least 3 kinds of infectious germs.On (b)(6) 2008 :a control radio was carried out, observing a the bascule of the pelvis.In 2009: new symptoms: the patient was short, of breath at the slightest effort (difficulty to walk, to move due to fatigue and weakness of the operated leg).The patient was treated with analgesics.On (b)(6) 2017: the control radio before the total hip revision.The report presents the hypothesis of a prosthetic detachment with formation of foreign body granuloma.On (b)(6) 2017: patient has severe pain on a metal-metal hip prosthesis with a large head and bone destruction on the femur.

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: no code available (3191) is used to capture (device revision or replacement.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.Addendum added: 14-april-2020.Following receipt of notification that this complaint involved asr mom products,this pi was re-opened.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: (b)(4) 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 will be filed as appropriate.

Event Description

Reason(s) for revision: pain in the right hip and abnormal sounds coming from the location of the implant.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.The complaint was received into the company with the following comment: the patient reports that the procedure and the rehabilitation was successful.(b)(6) 2007: lumbar pain appeared.2008: hip pain appeared with abnormal noises which resonated throughout the leg.The analyses was revealed at least 3 kinds of infectious germs (b)(6) 2008 :a control radio was carried out, observing a the bascule of the pelvis.2009 : new symtoms: the patient was short, of breath at the slightest effort (difficulty to walk, to move due to fatigue and weakness of the operated leg) the patient was treated with analgesics.(b)(6) 2017: the control radio before the total hip revision.The report presents the hypothesis of a prosthetic detachment with formation of foreign body granuloma.(b)(6) 2017: patient has severe pain on a metal-metal hip prosthesis with a large head and bone destruction on the femur.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 reported event is considered one of the possible complications of joint replacement.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicates that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.No information received with this individual complaint indicates that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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 will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, b6, b7, d11, h5, h6 (patient), h7, h9.Corrected: b1, b2, g1, g2, g3.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 report, a follow-up report will be filed as appropriate.

Event Description

After review of additional information, it was reported that the patient had a huge pseudo-vascularized tumour.The posterior aspect of the femur was completely devoured by the tumour.Ablation of the acetabular cup with scissors and hammer: there was a big posterior and anterior defect.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 49
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds IN LS11 8DT; UK LS11 8DT
• MDR Report Key: 9559537
• MDR Text Key: 188990340
• Report Number: 1818910-2020-00932
• 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: company representative,consum
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999890149
• Device Lot Number: 2285621
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR IMPLANT 56.; CORAIL2 STD SIZE 13.; LARGE MOD HEAD ADAPT 12/14 +5.
• Patient Outcome(s): Required Intervention