MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TOTAL ASR FEM IMP SIZE 51; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999804451

Device Problems Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Pain (1994); Scarring (2061); Osteolysis (2377); Ambulation Difficulties (2544)

Event Date 12/02/2011

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 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.

Event Description

Initial procedure, (b)(6) 2010 : right hip resurfacing utilizing a 58 mm depuy asr acetabular component with a size 51 depuy acetabulary femoral component.It was reported by legal that patient was revised on (b)(6) 2011 due to failed right asr hip resurfacing with increased metal ion levels.The post operative diagnosis was a failed right asr with acetabular fibrous union.Prior to revision: (b)(6) 2011 patient x-ray reviewed small cyst in zone 3 on acetabular side and a lytic lesion under femoral head (as per surgeon these were present to some degree on the post op x-rays) patient experienced pain.(b)(6) 2011 patient- elevated post metal ions, surgeon was not 100% certain that patient pain was from hip.

Event Description

Medical records received.After review of medical records for mdr reportability, patient was revised to address failed asr with acetabular fibrous union.Revision notes reported of large amount of scarring around the femoral neck, metal stained tissue in the acetabulum, 30 degrees of anterversion, grossly loose acetabular component and evidence of fibrous in-growth.Clinical notes reported pain, limping and elevated metal ions.X-rays shows a small cyst on acetabular side and lytic lesion under femoral head.Laboratory results for chromium metal ions is above 7ppb.

Manufacturer Narrative

(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.

• Brand Name: TOTAL ASR FEM IMP SIZE 51
• 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): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 45682-0988 ; 5743725905
• MDR Report Key: 7302376
• MDR Text Key: 101135303
• Report Number: 1818910-2018-54232
• 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,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2013
• Device Catalogue Number: 999804451
• Device Lot Number: 2571528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2018
• Date Device Manufactured: 01/28/2010
• 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: 47 YR