MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK SHOULDER GLENOID GLOBAL APG+

Catalog Number UNK SHOULDER GLENOID GLOBAL AP

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Muscular Rigidity (1968); Joint Laxity (4526)

Event Date 02/13/2021

Event Type  Injury  

Event Description

Literature article reviewed.Flynn jn, wijeratna m, evans m, lee s, taylor dm, hoy ga.Glenoid vault perforation in total shoulder arthroplasty: do we need computer guidance? shoulder elbow.2021 feb 13.Pmid: 33717224.The article's purpose was to evaluate outcomes of glenoid peg perforation testing the assumption that perforation produces worse results.Patient data: the mean patient age at surgery was 68 years and the mean duration of radiological and clinical follow-up was 46 months.Forty-five (58%) patients were female.Forty-four (53%) prostheses were in the dominant arm.Depuy products: global advantage or global ap with an anchor peg glenoid component.Cement manufacturer is not provided within the article.Adverse events: (7) glenoid vault perforation by the central peg ¿ no treatment noted; (1) aseptic glenoid loosening ¿ revision; (2) rotator cuff failure ¿ revision and arthroscopic cuff repair; (2) glenoid bone fracture ¿ revision and orif; (1) infection ¿ revision; (3) stiffness ¿ hydrodilatation and arthroscopic capsular releases; (1) instability ¿ plication of the posterior capsule.

Manufacturer Narrative

Product complaint # (b)(4).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.

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: UNK SHOULDER GLENOID GLOBAL APG+
• 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: 15074556
• MDR Text Key: 296302909
• Report Number: 1818910-2022-13633
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 07/21/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOID GLOBAL AP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 08/24/2022
• 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