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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 08/05/2012

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, "cementless modular total hip arthroplasty in patients younger than fifty with femoral head osteonecrosis: minimum fifteen-year follow-up" written by sang-min kim md, seung-jae lim md, young-wan moon md, yang-tae kim md, kyung-rae ko md, and youn-soo park md published by the journal of arthroplasty 28 (2013) 504¿509 accepted by publisher 5 august 2012 was reviewed.The article's purpose: "the purpose of this study was to report the clinical and radiographic results of cementless primary tha using a modular stem in a series of patients younger than fifty years with osteonecrosis of the femoral head who were followed for a minimum of fifteen years." the data was compiled from 64 hips (55 patients - 40 male and 15 female with average age of 40.2 years) with average follow up 15.8 years received implants from december 1994 to september 1996.Depuy products were utilized: srom femoral stem, cementless arthropore i or ii cup with poly liner in 60 hips and the remaining 4 hips were non-depuy cups.Bearing surfaces were cop (45 hips) and mop (19 hips).The article reports upon generalized results but also identifies 4 individual patients with adverse events that are capture on linked complaints.The article does not specify if patients received interventions based upon radiographic detections.The article reports "no hips showed femoral osteolysis without gross radiographic evidence of polyethylene wear and radiographic evidence of metallic debris.Loosening of femoral components was not seen in any of the cases in this series.This complaint captures a (b)(6) man who performed strenuous labor in squatting position and experienced ceramic head breakage at three years post index surgery and underwent liner and head exchange revision.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 ; 6103142063
• MDR Report Key: 9248279
• MDR Text Key: 177252511
• Report Number: 1818910-2019-112648
• Device Sequence Number: 1
• Product Code: KXA
• 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,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• 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
• Date Manufacturer Received: 12/24/2019
• 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
• Patient Age: 25 YR