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

Catalog Number 999800102

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

Patient Problems Tissue Damage (2104); Injury (2348); No Code Available (3191)

Event Date 05/28/2014

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

Please find attached details w.R.T asr hip implant first left leg total hip replacement was done on (b)(6) 2006 at (b)(6) hospital, (b)(6) and implant used was of depuy ref 9998-00-102, lot 2155140.First revision total hip replacement was performed on (b)(6) 2014 at (b)(6) hospital, (b)(6) and implant used was of depuy and left leg shortened by 5cm.Due to dislocation of implant second reverse thr done on (b)(6) 2014 at (b)(6) hospital (b)(6).As severe infection and watery discharge from operated area again she underwent removal of thr implant, debridement and antibiotic spacer insertion on (b)(6) 2015 at (b)(6) hospital (b)(6).Again infection and watery discharge from operated area she was admitted and surgery done on (b)(6) 2016 revision left thr for infection at (b)(6) hospital, (b)(6).Due to continuous pressure on right leg her knee of right leg pain started and knee replacement had to be done on (b)(6) 2018.As of now she is bedridden mentally disturbed and dependent physically and mentally on all family members for all day to day work.

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: the asr platform was voluntarily recalled from the market in (b)(4) 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: TAPER SLEEVE ADAPTER 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 8 DT; UK LS11 8 DT
• MDR Report Key: 8816240
• MDR Text Key: 151892959
• Report Number: 1818910-2019-99037
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999800102
• Device Lot Number: 2156140
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: CREATED IN ERROR; CREATED IN ERROR
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR