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

Catalog Number UNK SHOULDER HUMERAL STEM

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Review of literature article entitled: "one-stage revision for patients with a chronically infected reverse total shoulder replacement," by p.D.A.Beekman, et al., published j bone joint surg [br] 2010;92-b:817-22.A retrospective study of 11 consecutive patients with an infected reverse shoulder replacement, (manufactured by depuy international, no additional product or lot code information provided within the article), treated by a one-stage revision.All patients presented with obvious clinical picture of deep periprosthetic infection (swelling, redness, or a sinus tract).In three patients, the time from initial implantation to infection was less than three months (acute group).In each of these cases, debridement with retention of the prostheses was unsuccessfully attempted, prior to revision.Seven patients presented with infection occurring between 3 and 12 months post-primary implantation (sub-acute group).Finally, one patient presented with diagnosed infection occurring greater than 12 months post-implantation (late group).All patients were successfully treated with a single stage revision reverse shoulder arthroplasty, utilizing either depuy delta 3.2 or depuy delta xtend prosthesis, and long-term antibiotic therapy.This complaint will address the patient designated number 2, part of the acute group.There was evidence of a draining sinus preoperatively to revision.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.Device history lot: null.Device history batch: null.Device history review: null.

• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7429649
• MDR Text Key: 105431557
• Report Number: 1818910-2018-57362
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR