MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Pain (1994); Injury (2348); Joint Dislocation (2374); Osteolysis (2377); 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

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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)(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.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 ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9376356
• MDR Text Key: 185045156
• Report Number: 1818910-2019-116971
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention