MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +2; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999800312

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Tissue Damage (2104); Weakness (2145); Distress (2329); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189)

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.

Event Description

Legal claim received alleging that the patient suffers from pain, discomfort, soreness, malaise, swelling, and loss of energy.Alleged also is immobilization and both acute localized damage to tissue and/or bone surrounding the acetabulum and systemic injuries.Litigation also stated excessive levels of chromium and cobalt in patient's blood.Update rec¿d 09/26/2014 - plaintiff¿s preliminary disclosure form was received, which identified dob information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.The complaint was updated on: (b)(4) 2014.Doi: (b)(6) 2006; dor: none reported; (right hip).(b)(4).Event description: patient was revised due asr hip.Head, sleeve and cup removed.Doi - 2006, dor - (b)(6) 2017,right hip.Update ad 23 may 2018: (b)(4) were reopened under (b)(4).In addition to what was previously reported, litigation alleges suffering and emotional distress.Doi: (b)(6) 2006; dor: (b)(6) 2017; right hip.

Manufacturer Narrative

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).

Event Description

After review of medical records, patient was revised to address failed right total hip arthroplasty.Revision notes reported that there was some corrosion at the taper.

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: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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: ADAPTER SLEEVES 12/14 +2
• Type of Device: ASR HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7609703
• MDR Text Key: 111341210
• Report Number: 1818910-2018-62428
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2011
• Device Catalogue Number: 999800312
• Device Lot Number: 2164365
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2020
• 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: 63 YR