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

Catalog Number UNK SHOULDER METAGLENE

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Bone Fracture(s) (1870); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); 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

In the article entitled ¿reverse total shoulder arthroplasty after failed deltoid flap reconstruction¿ by alberto giuseppe schneeberger; timo marco muller; wolfram steens; and christoph thur; published in the arch orthopaedic trauma surgery january 23, 2014, was reviewed.The purpose of the article was to review the outcome of 19 patients after failed deltoid flap reconstruction treated with reverse shoulder arthroplasty.Follow-up was after a mean of 4.5 years.The product used was the delta iii (depuy, france).No intra-operative complications occurred.Seven patients had nine postoperative complications requiring 16 total revision surgeries.The complications that occurred are as follows: one patient obtained a humeral fracture four years after rsa.Two patients had infections.One patient experienced humeral polyethylene disassembly.Two patients experienced a painful bony spur at the inferior margin of the scapular neck.One patient experienced rsa instability presenting as ¿dead arm¿ syndrome.One patient experienced loosening of the glenoid component.One patient experienced hypersensitivity for nickel and cobalt.It was also reported that assessments were also done radiographically noting scapular notching in eight cases.Aside from the one case of glenoid loosening, no other humeral or glenoid loosening was noted.The article states that this study had important limitations including it was retrospective, had limited preoperative data.A longer follow-up in the series would be necessary to determine whether the defect of the deltoid muscle has a negative influence on the long-term outcome.

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.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) 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.Corrective action was not indicated.Device history lot : null.Device history batch : null.Device history review : null.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 METAGLENE
• Type of Device: SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9267274
• MDR Text Key: 177884678
• Report Number: 1818910-2019-113628
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER METAGLENE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention