MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN ELBOW IMPLANT

Catalog Number UNK ELBOW

Device Problems Loss of or Failure to Bond (1068); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2003

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.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 will be filed as appropriate.

Event Description

The literature article entitled "surface replacement of the rheumatoid elbow through a lateral approach¿ written by urban rydholm, md, phd, et al, published in techniques in orthopaedics in 2003; was reviewed.This article reports on the surgical technique and outcomes with the capitellocondylar elbow prosthesis (depuy).The capitellocondylar elbow is a chrome-cobalt resurfacing prosthesis with short intramedullary stems intended for cemented use.The authors report on early results with 50 capitellocondylar elbow followed for a median of three years.There were one major and 17 minor complications.Eight elbows required reoperation, in seven cases soft tissue surgery (two reconstructions of the radial ligament, three secondary wound sutures, and four ulnar nerve decompressions) and one case had prosthetic removal as a result of deep infection.No healing complications were seen in 45 elbows immobilized for two weeks postoperatively.Transient ulnar nerve palsy was recorded in 11 patients, whereas permanent nerve injury was seen in three patients.A few cases have been left with permanent radial translocation of the ulnar component without any significance for function, and one of them has been revises as a result of wear of the plastic inlay.Two patients have needed relocation and immobilization.Of the long-term follow-up.36 of 50 elbows in 42 patients operated on between 1989 and 1993 have now been examined after 10 years.Ten patients are deceased.One patient has been revised due to dep infection.Among the deceased patients, there was no infection, one radiographic loosening, and no revisions.In the living 31 patients with 36 operated elbow joints, no reoperation has been performed and all were satisfied with the outcome.Radiographic analysis has revealed only one case of loosening with a continuous radiographic zone greater than 2 mm, one case with a continuous radiographic 1-2mm zone and one case with ulnar cortical hypertrophy.

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 was received.Root cause undetermined.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 ELBOW IMPLANT
• Type of Device: ELBOW IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9467647
• MDR Text Key: 188267671
• Report Number: 1818910-2019-123057
• Device Sequence Number: 1
• Product Code: JDB
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ELBOW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1