MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL CUP

Catalog Number UNK SHOULDER HUMERAL CUP

Device Problem Naturally Worn (2988)

Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)

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.(b)(4).

Event Description

Literature article entitled: "can reverse shoulder arthroplasty be used with few complications in rheumatoid arthritis?", by anders ekelund md, et.Al, published in clin orthop relat res (2011) 469: 2483¿2488, doi 10.1007/s11999-010-1654-4, reviewed for mdr reportability.Study sought to retrospectively determine the benefits of reverse shoulder arthroplasty (rsa) for the patient with massive rotator cuff tears, superior humeral head migration, and rheumatoid arthritis.Their results showed that reverse arthroplasty in rheumatoid arthritis improved shoulder function with a low incidence of complications.Their study identified four complications for the 27 shoulders within the group (23 patients).During the selection criteria, four patients had been excluded from retrospective analysis because of death, not associated with the products or procedure.Another patient was excluded due to having had an unrelated stroke, preventing adequate evaluation of function.The article did not provide a break down of patients' information into identifiable subjects.The study indicated that patients had either delta iii rsa or delta xtend rsa, but did not identify which patients had which prosthesis.The technique used indicated that humeral stem components were cemented (cement manufacturer was not provided), with no ante- or retroversion, and the metaglene components were ingrowth, using 4 locking screws.The first complication was a perioperative event, a bone fracture of the glenoid rim that occurred during glenoid reaming in preparation of the metaglene implant.There was no operative intervention noted to address this bone fracture event.The second adverse event occurred five years after surgery, requiring revision to address shoulder instability due to polyethylene liner (humeral cup) wear.A replacement humeral cup insert with a lengthener (collar) was implanted to treat, with reportedly good clinical results post-revision.The third adverse event involved a patient who had a primary shoulder arthroplasty to reverse shoulder arthroplasty for inclusion in the study, that developed a deep infection within a year of implantation of the rsa (date of implantation is unknown, and duration of the infection from the date of implantation is also unknown).The patient underwent a successful two-stage revision, with good clinical results.Finally, the fourth complication involved a patient experiencing 6 months of ongoing severe pain at 9 years post-op.Ct scans and radiographs demonstrated no evidence of loosening.Surgical exploration identified that the central locking screw that connected the glenosphere to the metaglene had fractured within the metaglene, requiring removal of the well-fixed metaglene and revising both it, the four screws, and the glenosphere products.This report addresses two instance of the impacted product.

Manufacturer Narrative

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.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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.

Manufacturer Narrative

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.H10 additional narrative: product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER HUMERAL CUP
• Type of Device: SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8268671
• MDR Text Key: 133783351
• Report Number: 1818910-2019-81835
• 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: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention