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

Catalog Number 999890149

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

Patient Problems Edema (1820); Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Date 05/08/2016

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.(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

Update ad 12 dec 2019.(b)(4) has been reopened due to receipt of a claimsuite alert.It was indicated that the patient had undergone a revision due to alval/soft tissue reaction.Doi: (b)(6) 2009 - dor: (b)(6) 2016 (right hip).Update ad 19 dec 2019.Scf and operative notes received.Scf indicates that the patient had two revision surgeries due to component loosening, pain and alval/soft tissue reaction.The first was on (b)(6) 2016 to revise the cup.The second one was on (b)(6) 2017 for loosening of the stem.Operative notes on (b)(6) 2016 indicate that the patient had dark fluid within the hip joint, metallosis, synovitis.The patient had no signs of infection.The stem was noted to be well-fixed and was not revised.The acetabular component was removed very easily.There was no gross bone loss.Patient was implanted with a gription cup, 2 screws and a ceramic liner and ceramic head from unknown manufacturers.Surgeon confirmation form and operative notes received.Operative notes indicate that the patient was revised to address loosening of the stem.Femoral head, corail stem and ceramic liner were removed.Poly depuy liner was put in place along with a competitor head, stem and cement.The patient was noted to be clinically not infected.Doi: (b)(6) 2009 (stem); doi: (b)(6) 2016 (unknown femoral head and unknown liner); dor: (b)(6) 2017; (right hip).

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 : 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.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa- 001226.Ongoing post market surveillance is conducted per our procedures for this product.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: DEPUY ASR XL FEM IMP SIZE 49
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9558729
• MDR Text Key: 185381637
• Report Number: 1818910-2020-00900
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999890149
• Device Lot Number: 2831599
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/31/2020
• 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: 59 YR