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 Problems Pain (1994); Injury (2348); No Code Available (3191)

Event Date 05/01/2006

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 ¿treatment of glenohumeral arthritis with a hemiarthroplasty: a minimum five-year follow-up outcome study¿ by michael a.Wirth, md, r.Stacey tapscott, md, carleton southworth, ms and charles a.Rockwood jr., md was reviewed.The purpose of the article ¿treatment of glenohumeral arthritis with a hemiarthroplasty: a minimum five-year follow-up outcome study¿ was to describe the patient selection strategy, to discuss the technical methods that affected patient outcomes, and to test the hypothesis that hemiarthroplasty can provide sustained functional improvement and pain relief for at least five years.The article reports that 57 patients (64 shoulders) had hemiarthroplasty performed with general anesthesia while in a beach-chair position with a deltopectoral approach and all were treated with a depuy global shoulder modular prosthesis.Of those 57 patients, only 43 patients (50) shoulders were followed for a minimum of five years.The article indicates that four of the patients had complications.One patient (who was one of the original 57 patients), required revision surgery to a total shoulder arthroplasty less than two years after primary hemiarthroplasty.The patient had a gradual onset of pain with medial migration of the prosthetic head.No evidence of loosening of the humeral stem on radiographic evaluation, and no evidence of infection was found on culture specimens obtained during the revision operation.This could be concluded to be a joint instability issue and not due to implant migration.Two patients sustained early post-operative subscapularis ruptures and were treated with pectoralis major tendon transfer.The first of these two patients sustained a subscapularis rupture secondarily to an overly aggressive rehabilitation at a physical therapy center at approximately four weeks after surgery.The patient subsequently had development of anterior instability and underwent pectoralis major transfer at ten months.The other patient noted a slipping sensation of the humeral head at wo months and underwent pectoralis major transfer at three months.A nonfunctioning, attenuated subscapularis was noted at the time of reoperation.The fourth patient had idiopathic brachial plexus neuritis develop seven months following the operation.46 were also noted to have erosion of the glenoid at the most recent follow-up.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> the device associated with the reported event was not returned to the investigation site for evaluation.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.

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9211417
• MDR Text Key: 173798025
• Report Number: 1818910-2019-108977
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL STEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 12/03/2019
• 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