MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN SHOULDER HUMERAL STEMS

Catalog Number UNK SHOULDER HUMERAL STEM

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Synovitis (2094); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); 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: "humeral prosthetic failure of reversed total shoulder arthroplasty: a report of three cases", by lieven de wilde, md, et.Al, published in j shoulder elbow surg volume 15, number 2, reviewed for mdr reportability.Authors state that while it is generally accepted that most complications will involve the glenoid side of the construct, some humeral complications have already been encountered.Authors report two cases of unscrewing of the humeral prosthesis and one case of metallic failure of the medial epiphyseal calcar.Authors believe that these prosthetic failures can be explained either by errors in surgical technique or by the design of the prosthesis.This complaint will address the second of the three patients, case 2.Case 2: a (b)(6) man was treated with resection of the proximal humerus for plasmacytoma of his left shoulder.During the same operation, the excised proximal humerus was reimplanted after extracorporeal irradiation in combination with a depuy delta iii.1 total shoulder prosthesis (cementless humeral revision diaphysis, size 2 and length 18; cementless humeral epiphysis, size 42; no humeral lengthener; standard non-lateralized humeral cup; cementless metaglene and impaction glenosphere, size 42; and humeral stem implanted at 10° of anteversion).The postoperative course was uneventful, with a functional shoulder at 2 years of follow-up.At 4 years postoperatively, radiologic osseous cortical survival of the irradiated proximal humerus with no distal osseous integration but without component loosening was seen.A broad nonprogressive resorption line of 2 to 3 mm between the irradiated proximal humerus and the humeral prosthesis was consistently seen on radiographs.A few months later, the patient suddenly had pain during a forward flexion movement.The patient experienced pain at rest and loss of active function.Radiologic examination disclosed prosthetic failure of the epiphysis, fractured where the epiphysis joins the diaphysis.At the time of revision, no polyethylene wear was noticed, but the polyethylene component was completely loose.The glenoid component was stable even after separation of the glenosphere from the metaglene, but the humeral component was completely loose and surrounded by severe synovitis.A thorough synovectomy was done on the humeral and glenoid side.Because no loosening of the metaglene was seen, it was decided to leave it in place.The humeral component had to be changed and cemented.Generous osseous cancellous allografts were placed at the humeral calcar between the revised, non-cemented epiphyseal prosthesis and the remaining humeral cortical bone.

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.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 STEMS
• Type of Device: SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8278505
• MDR Text Key: 134126449
• Report Number: 1818910-2019-82339
• 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
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 01/25/2019
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR