MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR POLY/METAL HEMI

Catalog Number UNK HIP ACET. POLY/METAL

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

Patient Problems Erosion (1750); Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.Pma/510k: this report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).

Event Description

A literature article was received entitled: "is bipolar hemiarthroplasty a reliable option for ficat stage iii osteonecrosis of the femoral head? 15- to 24-year follow-up study", by kyu-tae hwang, et.Al, published in arch orthop trauma surg (2012) 132:1789¿1796.The study sought to determine reliability of bipolar hemiarthroplasty as a treatment for osteonecrosis of the femoral head.The depuy self-centering bipolar device was used on all 55 hips, paired with either a depuy trilock femoral stem (32 hips) or a depuy gemini femoral stem (23 hips), and an appropriate depuy metal femoral head, for a metal on polyethylene bearing in all hips.Ten hips were revised over the length of the study: two hips were revised for groin pain, associated with loss of acetabular cartilage and osteolysis, and the other eight were revised to address groin pain with superomedial migration of the cup with acetabular protrusion (erosion) and osteolysis.There were no reports of dislocation, stem loosening, or infection.The authors did not provide any case/patient specific accounts, nor any specific product or lot code information for any of the implanted products.This report addresses ten instances involving this product.

Manufacturer Narrative

(b)(4).Literature article review.No device associated with this report was received for examination.Depuy considers the investigation closed at this time.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR POLY/METAL HEMI
• Type of Device: HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8522380
• MDR Text Key: 142197559
• Report Number: 1818910-2019-90872
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACET. POLY/METAL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2019
• 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