MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

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

Patient Problems Pulmonary Embolism (1498); Bone Fracture(s) (1870); Unspecified Infection (1930); Myocardial Infarction (1969); Pneumonia (2011); Thrombosis (2100); No Code Available (3191)

Event Date 09/25/2019

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.(b)(4).

Event Description

The literature article entitled ¿patient-optimizing enhanced recovery pathways for total knee and hip arthroplasty in medicare patients: implication for transition to ambulatory surgery centers¿ written by alaine van horne, et al, published in arthroplasty today 5 (2019) 497-509 25 september 2019, https://doi.Org/10.1016/j.Artd.2019.08.008, was reviewed.The purpose of the study was to assess outcomes and feasibility of same-day discharge using a presurgical patient-optimizing, opioid-sparing eras pathway in medicare-insured patients undergoing tka/tha without home healthcare services.The pathway focused on expanding eligible patient population, improving patient satisfaction, reducing postsurgical complications and cost and minimizing the duration of postsurgical opioid use.Surgical technique was not discussed; no mention of patellar resurfacing or cement manufacturer.601 patients were gathered from a retrospective chart review who were medicare-insured patients who underwent primary inpatient tka or tha between june 1, 2015 and november 16, 2017.Patients were followed up with at 30 and 60 days.Tka adverse events: dvt/pe, return to surgery (no reason specified), uti, pneumonia, unplanned readmissions (due to pneumonia, myocardial infarction, ulcer/gastrointestinal complication, dvt), other and fracture.Tha adverse events: dvt/pe, return to surgery (no specified reason), deep wound infection, cerebrovascular accident, myocardial infarction, uti, pneumonia, unplanned readmissions (due to pneumonia, myocardial infarction, other, fracture and dislocation.

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.Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.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 ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9981292
• MDR Text Key: 188394525
• Report Number: 1818910-2020-11062
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention