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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The literature article entitled, "primary total hip arthroplasty with use of the modular s-rom prosthesis" written by michael j.Christie, m.D., david k.Deboer, m.D., lorence w.Trick, m.D., john c.Brothers, m.D., richard e.Jones, m.D., guy t.Vise, m.D., and thomas a.Gruen, m.S.Published by the journal of bone and joint surgery, incorporated 1999 was reviewed.The article's purpose was to report the clinical and radiographic results of primary total hip arthroplasty with insertion of the modular srom femoral stem without cement in a series of patients who were follows for four to seven years.Data was compiled from 175 hips implanted between january 1988 to september 1991.Depuy products utilized: srom femoral components, cocr femoral head, cementless cup, poly liner adverse events: intraoperative calcar fracture (intervention not clarified within article), intraoperative sciatic nerve injury (intervention and patient outcome not clarified within article), intraoperative pelvic vascular injury (intervention not clarified within article), recurrent dislocation (treated by revision to a restrained liner), periprosthetic femoral fracture (treated by revision to a longer stem), trochanteric fracture (related to osteolysis associated with poly liner wear), loose femoral stem (treated by revision), loose acetabular component (treated by revision - associated with osteolysis due to poly liner wear), progressive femoral component subsidence (treated by revision), radiographic findings: cortical thinning, osteolytic lesions in femur and acetabulum; reports of pain.

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.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 HEAD
• Type of Device: HIP FEMORAL HEAD
• 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 ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9376352
• MDR Text Key: 185046677
• Report Number: 1818910-2019-116968
• Device Sequence Number: 1
• Product Code: KXA
• 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,Followup
• Report Date: 11/07/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/31/2019
• 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