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 Pain (1994); Hip Fracture (2349); Osteolysis (2377); No Code Available (3191)

Event Date 01/01/2012

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 prospective, randomized study of cross-linked and non-cross-linked polyethylene for total hip arthroplasty at 10-year follow-up" by charles a.Engh jr., md, robert h.Hopper jr., phd, cathy huynh, bs, henry ho, ms, supatra sritulanondha, mph, and charles a.Engh sr., md published by the journal of arthroplasty vol.27 no.8 suppl.1 2012 doi:10.1016/j.Arth.2012.03.048 on 27 march 2012 was reviewed for mdr reportability.The article's purpose: " for this study we hypothesized that the reduced radiographic wear would be maintained and that clinical outcomes such as osteolysis and revision rates would be less for the cross-linked group." the patients in the data "were implanted on the acetabular side with a duraloc 100 (depuy) cup incorporating a 4-mm lateralized liner, unless intra-operative considerations dictated another type of prosthesis.The polyethylene liner was secured in the duraloc shell by a peripheral locking ring that engaged a groove machined into the liner and shell.On the femoral side, an extensively porous-coated stem (anatomic medullary locking, solution, or prodigy) (depuy) was used with a 28-mm cobalt-chrome alloy femoral head." noted are revision occurrences: "n 2 revisions in patients with a cross-linked bearing surface.One patient had an open reduction of a dislocation without exchange of components at 4.3 years after the index procedure.The second revision was a polyethylene and ball exchange for recurrent dislocation 8.3 years after the index primary.To date, eleven patients with a non¿crosslinked liner have undergone a reoperation.Two patients had a ball and polyethylene liner exchange for recurrent dislocation at 3.8 and 9.6 years, respectively.Nine patients had a ball and liner exchange for reasons related to implant wear.These revisions occurred between 6.0 and 12.7 years after the index surgery.Two of these nine also had an osteolytic fracture, one involving the lesser trochanter and the other involving the greater trochanter." adverse events: surgical intervention, pain, dislocation, implant wear, osteolysis, femur fracture.

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9087114
• MDR Text Key: 163321750
• Report Number: 1818910-2019-105113
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2019

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: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention