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

Catalog Number UNK SHOULDER GLENOID

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 02/18/2015

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.(b)(4).

Event Description

"the literature article entitled ¿five- to ten-year follow-up with a partially cemented all-polyethylene bone-in growth glenoid component¿ by matthew p.Noyes, pt, md; bradley meccia; and bs, edwin e.Spencer jr, md; published in the journal of shoulder and elbow surgery, february 2, 2015, was reviewed.The article¿s purpose was to determine the five-to-ten-year follow-up of a curved-back partially cemented bone-ingrowth all-polyethylene glenoid component.The hypothesis was that bone incorporation of the fluted central peg would be associated with fewer lucent lines around the peripheral pegs and correlate with validated outcomes measures.42 patients were followed-up with over a mean time of 80 months.All had the depuy global advantage arthroplasty implanted with a partially cemented bone-ingrowth glenoid component.The article does not report any complications, however does report that humeral calcar osteolysis was present in 14 shoulders, possibly secondary to infection and/or reaction to polyethylene debris.The article also reports that mechanical loosening of the glenoid component was represented by the increase of lucent lines.Only one revision was necessary from this study.".

Manufacturer Narrative

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.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 GLENOID
• Type of Device: GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9323386
• MDR Text Key: 183372047
• Report Number: 1818910-2019-114016
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOID
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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