MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 DEPUY ASR XL FEM IMP SIZE 46; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890146

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Tissue Damage (2104); Discomfort (2330); Injury (2348)

Event Date 12/15/2015

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.No 510(k) number provided because this implant product code was sold internationally.It was sold in the us under a different product code.The correction/removal reporting number listed applies to the corresponding product code sold domestically.

Event Description

Initial procedure, (b)(6) 2008 : left total hip replacement.Patient was originally implanted with size 46 asr unipolar femoral component, asrtaper sleeve adaptor and size 52 asr total acetabular component.Preoperative diagnosis-severe left coxarthrosis (prior to (b)(6) 2008 surgery).It was reported by legal that the patient was revised on (b)(6) 2015 patient had a total left hip revision.The pre-op diagnosis was a pseudotumor and contained bone loss (left femur and left acetabulum).The surgery involved removal of the left hip pseudotumor, revision of the acetabular cavity, total left hip replacement.Allograft-left acetabulum and left femur.(b)(6) 2018: medical records and translated document received.After review of medical records for mdr reportability, it was indicated that the patient was revised due to pseudotumor type tissue reaction to a total left hip replacement with contained bone loss.The revision notes report that when they opened the junction between the scar tissue and the posterior part of the greater trochanter, a large amount of greenish serous fluid was found.An abnormal tissue reaction with greenish hyperplastic tissue in the back of the hip prosthesis and brownish hyperplastic tissue in front was also observed.Presence of metallosis at the junction between the head, neck and femoral prosthesis was also noted.It was observed that on the posterior side of the femoral prosthesis, there was an enormous cavity which required an allograft.It was also reported that there were some contained bone loss in the anterior and inferior areas of the acetabular component and these areas were cleaned with a curette to remove poor-quality tissue.Clinic visits show that patient had intermittent pain, discomfort and metallosis.Ultrasound confirms fluid buildup.Lab results also indicate elevated c-reactive protein, chromium and cobalt ion levels.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 46
• 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
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7352371
• MDR Text Key: 102864410
• Report Number: 1818910-2018-55529
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

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 Expiration Date: 03/08/2012
• Device Catalogue Number: 999890146
• Device Lot Number: 2345979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 08/16/2018
• Date Device Manufactured: 03/15/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR