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 Ossification (1428); Unspecified Infection (1930); Injury (2348); No Code Available (3191)

Event Date 10/26/2013

Event Type  Injury  

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.

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, "long-term results and bone remodeling after tha with a short, metaphyseal-fitting anatomic cementless stem" written by young-hoo kim, md, jang-won park, md, jun-shik kim, md, and jun-seok kang, md published by clinical orthopaedics and related research published online 26 october 2013 was reviewed.The article's purpose was to review long term results of in total hip arthroplasties in utilizing depuy cementless immediate postoperative stability stem (ips).Data was compiled from 500 patients (630 hips) age range 20-63 years.The article provides figure 2a-b for radiographic imaging noting a (b)(6) male with "acetabular and femoral components are well fixed in a satisfactory position in both hips without osteolysis.Grade 2 calcar resorption is evident in both hips, but periprosthetic bone stock is well preserved without having stress shielding-related bone osteopenia." depuy products utilized: ips stem, duraloc cup, ceramic on ceramic bearing adverse events: reports of clicking sound (no information regarding interventions) leg length discrepancy of less than 2 mm (no interventions required) calcar stress shielding by radiographic detection (no interventions required) heterotopic ossification by radiographic detection (no impact on function and no interventions required) infection (treated by revision of femoral and acetabular components) dislocation (treated by revision of acetabular components).

• 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
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9632788
• MDR Text Key: 185354938
• Report Number: 1818910-2020-03034
• Device Sequence Number: 1
• Product Code: KWY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• 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
• Date Manufacturer Received: 02/27/2020
• 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