MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER GLENOID

Catalog Number UNK SHOULDER GLENOID

Device Problem Osseointegration Problem (3003)

Patient Problems Fatigue (1849); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The article indicates 1 patient died and 1 was excluded due to hemiplegia at the operated side secondary to intracerebral bleeding unrelated to the shoulder surgery.There is no indication within the article that suggest depuy components caused or contributed to the patient death or intracerebral bleeding.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article entitled ¿clinical and radiographic outcomes of an all-polyethylene fluted central peg glenoid component, implanted utilizing an off-label, uncemented technique, at a minimum 5-year follow-up"" written by matthijs jacxsens, md, nader dayerizadeh, md, dominiek vandenbosch, pt, alexander van tongel, md, phd, lieven de wilde, md, phd.Published by journal of shoulder and elbow surgery; published online 01 january 2020 was reviewed.The article's purpose was to evaluate the clinical and radiographic results of a fully uncemented all-polyethylene fluted central peg bone-ingrowth glenoid component at a minimum 5-year follow-up.Patient data: thirty-five shoulders in 31 patients (mean age, 73 years) with a mean follow-up of 100 months.10 male, 21 female.Depuy products: depuy anatomic tsa using an anchor peg glenoid implanted in a cementless fashion.Specific depuy product line was not provided within the article.Non-patient specific adverse events: (2) asymptomatic aseptic glenoid loosening ¿ treated with revision.(1) subscapular insufficiency ¿ treated with revision.(1) septic glenoid loosening secondary to a low-grade infection ¿ treated with revision.(1 - specific number not provided) radiolucencies, decreased mobility, decreased strength, decreased activity, and increased pain ¿ no treatment indicated.Patient specific adverse events - 69-year-old female: (1) radiographic signs of loosening with osteolytic areas and progressive radiolucencies around all pegs, as seen on ct scan at 94 months of follow-up.Treatment not described within the article.

Manufacturer Narrative

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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN SHOULDER GLENOID
• Type of Device: SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15051891
• MDR Text Key: 296139760
• Report Number: 1818910-2022-13373
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOID
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• 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