MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL AUGMENT

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 09/29/2017

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

Complications post-op.This case is from health authority.It was reported that on (b)(6) 2006, the patient underwent right hip surface replacement for osteonecrosis of the femoral head, and the postoperative recovery was good.The patient felt the hip joint swelling and painful, claudication, difficulty in weight bearing, decreased physical activity, local tenderness for 3 months.Took x-ray on (b)(6) 2017 and it showed osteoporosis around the acetabular prosthesis and around the femoral stem.The concentration of co-cr in blood and urine was significantly increased, and revision hip arthroplasty was performed.

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)(6).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9347560
• MDR Text Key: 184995309
• Report Number: 1818910-2019-117149
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• 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