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 Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 05/01/2009

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 ¿humeral head arthroplasty and meniscal allograft resurfacing of the glenoid¿ published in the journal of bone and joint surgery, volume 91-a, number 5 in may of 2009, was reviewed.The purpose of the report was to (1) to describe a technique that was developed to facilitate biological resurfacing of the glenoid with the use of meniscal allograft tissue and (2) report the effectiveness of hemiarthroplasty in conjunction with meniscal allograft glenoid resurfacing in patients who were 53 years of age or less.All patients had shoulder arthroplasty between september 2001 and september 2006 with a depuy global shoulder modular prosthesis.Clinical assessments were performed preoperatively and at one-year intervals postoperatively for at least two years.27 patients were followed for the minimum of two years according to the study protocol.At a mean follow-up interval of 35 months, there was improvement both in the pain score and in the shoulder range of motion.All patients returned to their preoperative employment, and there was notable improvement in sports-related activities.Radiographic findings found that 26 shoulders showed no subluxation and only one showing moderate subluxation.There were three complications in three shoulders that underwent reoperations.One patient developed a superficial infection ten days following surgery.The infection was successfully managed with would debridement and 48 hours of iv antibiotics.The second patient had shoulder discomfort when he returned to ranch work, against medical device, at six weeks following surgery.The discomfort gradually increased over several months despite modification.He under went reoperation, 14 months after the index procedure, and it was found the lateral meniscal allograft was noted to be displaced from the glenoid articular surface.The graft was excised, and the glenoid was revised to a minimally cemented, polyethylene glenoid component.The third patient developed an infection six weeks post operation that required operative debridement and revealed methicillin-resistant staphylococcus aureus.The patient requested resection arthroplasty.Two other patients had additional surgery at 32 and 36 months due to a gradual increase in pain.At the time of operation, both shoulders demonstrated degeneration of the meniscal allograft tissue.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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, IN 46581-0988 ; 6103142063
• MDR Report Key: 9427952
• MDR Text Key: 185264866
• Report Number: 1818910-2019-121618
• 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: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2020
• 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