MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994); Pressure Sores (2326); Blood Loss (2597); No Code Available (3191)

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.

Event Description

On 27-june-2019 literature article entitled: ¿hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial¿ the study¿s objective was to compare the functional results after displaced fractures of the femoral neck treated with internal fixation or hemiarthroplasty.The models of prostheses used include charnley-hastings bipolar cemented hemiarthroplasty.Please note, cement manufacturer is not provided.The study identified the following to be adverse outcomes, patient quantity is stated if provided: 35 blood loss requiring blood transfusion.15 intra-operative complications ¿ not otherwise specified.20 post-operative confusion.2 wound dehiscence.1 heterotopic ossification.1 pressure sore.1 radiographic loosening of hemiarthroplasty.1 dislocation of hemiarthroplasty.7 deep infection; pain.Revision / re-operation / soft tissue debridement.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.H10 additional narrative: product complaint #(b)(4).Investigation summary: 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.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8802585
• MDR Text Key: 151437914
• Report Number: 1818910-2019-98652
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

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 STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention