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

Catalog Number UNK SHOULDER HUMERAL HEAD

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

Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Injury (2348); Fibrosis (3167); Not Applicable (3189); No Code Available (3191)

Event Date 06/26/2013

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

The literature article entitled ¿humeral surface replacement for osteoarthritis¿ by tomas smith, andre gettmann, mathias wellmann, frederic pastor, and melena struck, published in acta orthopaedica june 26, 2013, was reviewed.The purpose of the article was to investigate the authors¿ hypothesis that preoperative flenoid wear and postoperative progress of glenoid erosion would influence the clinical outcome.61 resurfacing hemiarthroplasties (55 patients) for primary osteoarthritis.Six patients were lost to follow-up and five had undergone revision arthroplasty.This left 50 shoulders in 44 patients that were followed for a mean of 30 months.In the total population of 61 shoulders, the radiographs showed postoperative glenoid erosion in 38 cases and no humeral prosthetic loosening.Revision arthroplasty was performed in 11 cases after 28 months.The implant used was the global c.A.P.(depuy).Complications were: one intraoperative diaphyseal fracture of the humerus was treated by plate osteosynthesis.One deep hematoma developed and required revision surgery.One deep infection required revision surgery 20 days postoperatively without implant removal.Five cases of arthrofibrosis were noted and underwent arthroscopic capsular release with good functional results.Revision arthroplasty was performed in 11 cases, four of which were revised to reverse total shoulder arthroplasty were revised due to a rotator cuff tear, glenoid erosion, pain and/or infection.Radiographic results showed no sign of loosening at the time of final follow-up.Only one case showed superior migration of the humeral head after rotator cuff tear.No injury of neurovascular structures or gross malpositioning of the implants occurred.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.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 HEADS
• Type of Device: SHOULDER HUMERAL HEADS
• 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, IN 46581-0988 ; 6103142063
• MDR Report Key: 9322329
• MDR Text Key: 184993801
• Report Number: 1818910-2019-115552
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer 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