MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL STEMS

Catalog Number UNK SHOULDER HUMERAL STEM

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

Patient Problem Death (1802)

Event Date 01/01/2009

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Report source of information is a literature article-so there is limited information regarding the death.(b)(4).

Event Description

The literature article entitled ¿shoulder arthroplasty records¿ by geraldo motta filho; marcus vinicius galvao; martim monteiro; marcio cohen; and bruno brandao; published in sociedade brasileira de ortopedia e traumatologia in 2009, was reviewed.The objective of the paper is to analyze the data stored in the registry of shoulder arthroplasties performed by the shoulder and elbow surgery clinic of the national institute of traumatology and orthopedics (into) in order to document the epidemiological characteristics of patients undergoing this procedure, defining the clinical-surgical profile and technical variables related to this type of orthopedic surgery and to perform functional analysis of these patients in the future.145 shoulder arthroplasties performed in between august 2004 and november 2006 by the scoc of the into, were analyzed to try to identify the epidemiological information related to this procedure.All patients were divided into three groups¿degenerative joint disease, acute trauma and traumatic sequelae.All surgical procedures used the global total shoulder system prostheses (depuy).Some patients had a partial arthroplasty and some had a total arthroplasty.As for associated injuries, one patient had a brachial plexus neuropraxia with spontaneous complete resolution after three months of the initial trauma, after being treated only with occupational therapy, and one patient had an ipsilateral femoral neck fracture treated surgically with hemiarthroplasty in a first surgical procedure in the trauma surgery clinic at the same institution.The recent complications that occurred were an injury to the axillary artery during surgery in a case of anterior inveterate fracture-dislocation, two cases of instability, one anterior and one posterior; cases of traumatic sequelae included urinary sepsis in a type ii diabetic patient without apparently compromising the implant, and the death of an elderly patient with a fracture as the result of clinical postoperative complications.

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.Corrected: h6.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 SHOULDER HUMERAL STEMS
• Type of Device: SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9336739
• MDR Text Key: 166835150
• Report Number: 1818910-2019-115093
• Device Sequence Number: 1
• Product Code: KWS
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death