MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVE 11/13 +6; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999890346

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

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Tissue Damage (2104); Weakness (2145); Anxiety (2328); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation papers allege the patient experienced pain, stiffness, discomfort, and weakness, which in turn negatively affects thepatient's mobility and quality of life.Papers also allege excessive levels of chromium and cobalt blood levels.Doi: (b)(6) 2009 dor: no information (right side ).Patient is a resident of (b)(6).Update (10/23/2012) - patient fact sheet was received.The part/lot numbers have been updated.There is no new information that would change the outcome of the investigation.Update ad 17 apr 2019: (b)(4) has been re-opened under (b)(4) due to asr litigation records received.In addition to what were previously alleged, litigation alleges injury, anxiety and emotional distress.Doi: (b)(6) 2009; dor: (b)(6) 2018; right hip.

Manufacturer Narrative

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.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 report, a follow-up report will be filed as appropriate.

Event Description

After review of medical records, patient was revised to address asr metal on metal right total hip arthroplasty with persistent pain.Revision notes stated that pericapsular tissues were excised.There was a great deal of scar tissue proximally on the femur.Discharge summaries reported right hip total hip arthroplasty causing metallosis.Doi: (b)(6) 2009 - dor: (b)(6) 2018 (right hip).

• Brand Name: ADAPTER SLEEVE 11/13 +6
• 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: 10109143
• MDR Text Key: 193360082
• Report Number: 1818910-2020-13001
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: 999890346
• Device Lot Number: 2863158
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVE 11/13 +6; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; SROM*STM ST,36+8L NK,18X13X160; ADAPTER SLEEVE 11/13 +6; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; SROM*STM ST,36+8L NK,18X13X160
• Patient Outcome(s): Required Intervention