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

Catalog Number UNK SHOULDER IMPLANT

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

Patient Problems Bone Fracture(s) (1870); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Unspecified Tissue Injury (4559)

Event Date 07/23/2022

Event Type  Injury  

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.

Event Description

Article entitled ¿a sequential approach to the management of posterior glenoid defects in rsa" written by shinji imai, md, phd, published by the journal of bone and joint surgery was reviewed.No published date provided.Large posterior glenoid defects pose problems in reverse shoulder arthroplasty (rsa).We have adopted a sequential approach to the management of posterior glenoid defects using asymmetrical reaming, the placement of a ring graft around the central peg (bony-increased offset, or bio), or structural bone-grafting, depending on the amount of glenoid retroversion.Furthermore, we have devised multiple bioresorbable pinning (mbp)-assisted bone-grafting, in which as many bioresorbable pins as required are inserted, from whichever aspects of the graft necessary, to achieve initial stability the results of the present sequential approach to management of posterior glenoid defects by the 3 modalities were acceptable.The present mbp-assisted bone-grafting procedure is an effective treatment for cases of shoulder arthropathy with severe posterior glenoid defects.Angulated ring grafting around the central peg may yield equally acceptable results, although its graft-incorporation rate requires further follow-up.Patients underwent 1 of 3 different therapeutic modalities, depending on retroversion angles.A superolateral approach was used in all 52 primary rsas, with the aequalis reversed shoulder arthroplasty (tornier) prosthesis used in 34 shoulders, and the delta xtend (depuy orthopaedics) used in 18 shoulders, no cases required revision surgery of the glenoid component for implant loosening.Complications were noted to be: 6 scapular notching; 1 glenoid fracture; 1 case of transient brachial plexus palsy; 1 acromion fracture ; 2 transient brachial plexus palsy; the study also looks at pain and functional impairment.No medical or surgical intervention was noted.

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 IMPLANT
• Type of Device: SHOULDER IMPLANT
• 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: 15187940
• MDR Text Key: 297492798
• Report Number: 1818910-2022-15358
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• 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