MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN SHOULDER LOCKING SCREW

Catalog Number UNK SHOULDER LOCKING SCREW

Device Problems Fracture (1260); Loss of Osseointegration (2408)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

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.

Event Description

Article reviewed entitled: "conversion to hemiarthroplasty as a salvage procedure for failed reverse shoulder arthroplasty", by michael c.Glanzmann, md, et al, published in the journal of shoulder and elbow surgery.Authors reported on 16 patients who were revised to hemiarthroplasty following failed reverse shoulder arthroplasty.Seven of the sixteen patients originally had depuy delta iii reverse shoulder arthroplasty implants.Each of the seven patients will be reported on a separate complaint.This complaint addresses patient 3, a rheumatoid arthritis patient revised for glenoid construct loosening and implant fracture of locking screw, at a reported 12.8 years after primary, with conversion to hemiarthroplasty.

Manufacturer Narrative

(b)(4).No device was returned.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 LOCKING SCREW
• Type of Device: SHOULDER LOCKING SCREW
• 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: 7318171
• MDR Text Key: 101654050
• Report Number: 1818910-2018-54628
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER LOCKING SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2018
• 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: 57 YR