MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK SHOULDER HUMERAL STEM GLOBAL

Catalog Number UNK SHOULDER HUMERAL STEM GLOB

Device Problem Osseointegration Problem (3003)

Patient Problems Pain (1994); Joint Laxity (4526); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2020

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.

Event Description

The literature article titled, "salvage reverse total shoulder arthroplasty for failed anatomic total shoulder arthroplasty: a cohort analysis" written by r.Stephen otte, md, amanda j.Naylor, ma, kassandra n.Blanchard, ma, jourdan m.Cancienne, md, william chan, ma, anthony a.Romeo, md, grant e.Garrigues, md, and gregory p.Nicholson, md published by elsevier journal of shoulder and elbow surgery 2020 was reviewed.The article's purpose was to analyze the results of rtsa (revers total shoulder arthroplasty) as a revision salvage procedure for failed tsa (total shoulder arthroplasty) and identify factors that influenced those outcomes.Data was compiled from 75 patients (32 men and 43 women).It is noted that depuy products are listed amongst the failed tsa cases along with non depuy products.Finding results were the rtsa can improve pain, function and quality of life measures the article does not identify cement manufacturer.Involved tsa constructs were global/global ap (qty 7), global cap (qty 1), global unite (1).Constructs utilized in revision to rsa were not identified.The article reports majority of patients had multiple indications for revision rtsa, , and the article does not identify which products are associated with the revision reasons.Therefore exact quantities associated with each specific adverse event cannot be determined.Depuy products: global ap stem, global ap head, global ap glenoid (also utilized with cap in tsas), global unite stem, global unite proximal body, global unite cup, global unite glenosphere, global unite metaglene, 2 locking screws, 2 non-locking screws, global cap humeral head.Reasons for revision of tsa: septic loosening (no further information provided), glenoid loosening, humeral loosening, pain, rotator cuff failure, unstable arthroplasty.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK SHOULDER HUMERAL STEM GLOBAL
• Type of Device: SHOULDER HUMERAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11229449
• MDR Text Key: 228845436
• Report Number: 1818910-2021-01818
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL STEM GLOB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention