MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Bone Fracture(s) (1870); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 02/01/2018

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.(b)(4).

Event Description

The literature article entitled ¿a novel use of a tibial cone in a proximal femoral replacement¿, written by hilary koech, bs, et al, published in arthroplasty today4 (2018) 175-179, 1 february 2018, was reviewed.The case study was presented in the article to demonstrate a novel approach to femoral reconstruction in revision tha where a highly porous tantalum tibial cone was used in conjunction with a proximal femoral replacement in a patient with substantial bone loss after a prior apc failure.Depuy products used: s-rom modular hip system, depuy.A (b)(6) year-old woman with a history of congenital hip dysplasia underwent a primary tha at the age of (b)(6), in 1975.In 1995, she had a revision tha to a modular system (depuy) with an associated wire at the level of the metaphyseal sleeve.In 2006, the patient presented with severe start-up pain and antalgic gait.Radiographs demonstrated severe osteolysis, secondary to metal debris from the wire eroding through the sleeve resulting in bone loss and component loosening.The patient was revised to a long s-rom apc component supplemented by lateral femoral strut grafts.One week postoperatively, she heard a pop, and she sustained a periprosthetic distal femoral shaft fracture at the tip of the stem.A subsequent revision, involving a similar apc 6 cm or longer, was completed.At the one-year postoperative visit, she had no pain, ambulated without an assistive device, and radiographs demonstrated a well-positioned revision apc.At the four-year postoperative visit in 2012, she had radiographic evidence the stem was loose, and beginning to subside and at this time she had no desire to undergo revision surgery, given her lack of symptoms.In 2016, she presented with worsening left thigh pain for the last two years, and the sense of her left leg getting shorter.Radiographs demonstrated massive subsidence of the stem distally through the lateral femoral condyle.The patient underwent a left proximal femoral replacement with tibial cone (competitor cone).Then patient then eventually underwent tha revision with a proximal two-thirds femoral replacement.There was extensive heterotopic ossification around the acetabulum.The acetabular component was retained, a new dupuy duraloc liner was placed.Postoperatively, she experienced two hip dislocations at 6 months and one year and underwent successful closed reduction in the er on both occasions.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10040304
• MDR Text Key: 190384588
• Report Number: 1818910-2020-11924
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention