MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL SHD END PEG GLEN 40; GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID

Catalog Number 113784025

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 01/12/2018

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

Revision anatomical tsr, dr.(b)(6), (b)(6) hospital, (b)(6) 2018.Primary performed by a different surgeon, (b)(6) 2008.Patient complained of 12 months of mild shoulder pain.Shoulder arthroscopy performed 2 weeks ago & glenoid noted to be loose.Pathology notes increased crp & staph.Infection.Surgeon removed glenoid, head and then stem with taper attached, as stem was loose.Synovial tissue & glenoid component sent off by surgeon to be cultured.Implanting new stem, taper and head.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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: GLOBAL SHD END PEG GLEN 40
• Type of Device: GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380 ; 6103142063
• MDR Report Key: 7233815
• MDR Text Key: 98761207
• Report Number: 1818910-2018-52532
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10603295007227
• UDI-Public: 10603295007227
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K905786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 113784025
• Device Lot Number: A2PBC1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2018
• Date Device Manufactured: 11/14/2006
• 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