MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEM FEM STEM 13X150MM BOW HIP FEMORAL STEM

Catalog Number 198715213

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Abscess (1690); Calcium Deposits/Calcification (1758); Bone Fracture(s) (1870); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Weakness (2145); Anxiety (2328); Discomfort (2330); Ambulation Difficulties (2544); Fibrosis (3167); No Code Available (3191)

Event Date 08/23/2019

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. Occupation is a non-healthcare professional.

Event Description

Medical records received. After review of the medical records, the patient was revised to address infection resulting to pain, swelling, redness, weakness instability, loosening of the distal stem, subsidence of the femoral stem, heterotopic ossification to a the acetabular component. Operative note reported dense fibrinous tissue surrounding the implant proximally. This was sent for culture however no acute inflammation to suggest presence of infection. Fracture at the proximal most portion of the femoral stem. Doi: (b)(6) 2017; dor: (b)(6) 2019: right hip.

• Brand Name: LPS CEM FEM STEM 13X150MM BOW
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10275842
• MDR Text Key: 198900976
• Report Number: 1818910-2020-15893
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 198715213
• Device Lot Number: 661626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/15/2020 Patient Sequence Number: 1