MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK SHOULDER TAPER ASSEMBLY GLOBAL

Catalog Number UNK SHOULDER TAPER ASSEMBLY GL

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

Patient Problems Unspecified Infection (1930); Muscular Rigidity (1968); Joint Laxity (4526)

Event Date 02/13/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

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).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 TAPER ASSEMBLY GLOBAL
• Type of Device: SHOULDER TAPER ASSEMBLY
• 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: 15074551
• MDR Text Key: 296302882
• Report Number: 1818910-2022-13632
• Device Sequence Number: 1
• Product Code: LPH
• 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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER TAPER ASSEMBLY GL
• 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