MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER GLENOID

Catalog Number UNK SHOULDER GLENOID

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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Loss of Range of Motion (2032); Inadequate Osseointegration (2646); No Code Available (3191)

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 ¿clinical and radiographic results of an all-polyethylene pegged bone ingrowth glenoid component¿ by malin wijeratna, bsc (hons), mbbs, frcs (tr&orth); david mcd taylor, mbbs, md, mph, drcog, facem; steven lee, mbbs, franzcr; gregory hoy, mbbs, fracs (orth); and mathhew c.Evans, mbbs, fracs (orth), published in the journal of bone and joint surgery, volume 96-a, number 13, july 6, 2016 was reviewed.The articles purpose was to (1) evaluate the early clinical outcomes of the use of this prosthesis and compare them with the published results associated with this implant; (2) to evaluate with radiographs and computed tomography (ct) the presence of osseous in-growth, prevalence and severity of radiolucent lines at the bone-implant interface, and component orientation; (3) to identify any correlation between early clinical outcomes and radiographic appearance; and (4) to determine whether the clinical and radiographic outcomes deteriorated with time.All shoulder replacements were performed with the global advantage or global ap with an anchor peg glenoid component (depuy).Out of the 83 implants included in the study, four glenoid implants were revised, although only one was due to aseptic loosening; the others were due to rotator cuff failure, glenoid fracture, and infection.Two prostheses were revised to a reverse-geometry prosthesis, one glenoid component was revised to a keeled design, and one was revised to a hemiarthroplasty.Out of the 83 implants, there were six complications requiring additional surgical procedures.One was a glenoid fracture requiring open reduction and internal fixation during implantation of the glenoid prosthesis, and the other five required postoperative intervention (three cases stiffness [one requiring hydrodilatation and two requiring arthroscopic capsular releases], one cuff tear requiring plicaiton of the posterior aspect of the capsule).There was 0% loosening rate in this series.

Manufacturer Narrative

Product complaint # (b)(4).Patient code: no code available (3191) is also being used to capture medical device removal.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER GLENOID
• Type of Device: UNKNOWN SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9328435
• MDR Text Key: 182808376
• Report Number: 1818910-2019-114030
• 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,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• 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
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention