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

Catalog Number UNK SHOULDER LOCKING SCREW

Device Problem Loss of Osseointegration (2408)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report pertains to four instances of the same product.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 4, revised for aseptic glenoid construct loosening, at a reported 4.8 years after primary, with conversion to hemiarthroplasty.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial 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: 7318353
• MDR Text Key: 101660126
• Report Number: 1818910-2018-54634
• Device Sequence Number: 1
• Product Code: KWT
• 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

• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 04/18/2018
• Supplement Dates FDA Received: 04/26/2018
• 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: 82 YR