MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER LOCKING SCREW; SHOULDER HUMERAL STEMS

Catalog Number UNK SHOULDER LOCKING SCREW

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

Patient Problems Unspecified Infection (1930); Injury (2348); No Code Available (3191)

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.(b)(4).

Event Description

Literature received entitled: "observations on retrieved humeral polyethylene components from reverse total shoulder arthroplasty", published in j shoulder elbow surg (2010) 19, 1003-1012.The authors study sought to evaluate fourteen humeral polyethylene articulation components which were retrieved from revision surgery.Each polyethylene was analyzed for 9 modes of damage in each of 4 quadrants into which the bearing surface was divided.For each implant, the most recent radiographs before removal were scored using an adapted radiolucency score, and glenosphere positioning was measured.Of these fourteen components, 9 were manufactured by depuy.Of these shoulders, the following results were obtained: four depuy reverse shoulders were revised due to dislocation/instability of the reverse total shoulder prosthesis, with ensuing component revision of the humeral cup and the glenosphere (no additional information was provided).Five depuy reverse shoulders were revised due to infection, with ensuing explantation of the reverse total shoulder implants, and placement of an antibiotic spacer for treatment (no additional information was provided).With respect to the analysis of humeral cup polyethylene wear damage types, the quantity of each humeral cup affected was not broken down by specific manufacturer.The damage types that were identified during analysis of the revised depuy humeral cups are: damage type.Scratching.Abrasion.Embedded third body.Pitting.Burnishing.Surface deformation.Fracture.Wear-through.Scapular notching was demonstrated in 59% of the pre-revision radiographs available for depuy components.The severity of notching was not provided.Pre-revision glenoid construct lucencies (superior, inferior, central column and screws) were present in 85% of the total cases (11 of 13 shoulders reviewed-both manufacturers).Pre-revision humeral radiolucencies were appreciated in 69% of the total cases (9 of 13 shoulders reviewed-both manufacturers) available for review.It was noted though, that despite evidence of scapular notching, glenoid construct and humeral lucency, there were no cases of implant loosening identified during the revision surgeries.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER LOCKING SCREW
• Type of Device: SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9086290
• MDR Text Key: 163570332
• Report Number: 1818910-2019-105372
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER LOCKING SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention