MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL SHD END PEG GLEN 44; GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID

Catalog Number 113785025

Device Problem Osseointegration Problem (3003)

Patient Problems Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 06/27/2018

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 total shoulder replacement, dr (b)(6), (b)(6) hospital on (b)(6) 2018.Primary total shoulder replacement was carried out by dr.(b)(6) on the (b)(6) 2007.The patient complained of a painful shoulder.The surgeon had xrays carried out on the shoulder and it was noted that there was substantial osteolysis of the glenoid medial to the prosthesis.A revision total shoulder replacement was carried out by the surgeon on the (b)(6) 2018.The surgeon removed the humeral head and the glenoid prosthesis.During exposure of the glenoid the surgeon noted that the glenoid prosthesis was loose and could be removed without the aid of instruments.An anatomic tsr revision was carried out as the rotator cuff was still intact, the patients age and the fact that the patient had a plate on the humerus.The glenoid vault was bone grafted using femoral allograft, an anchor peg glenoid was implanted and a global advantage humeral head was attached to the stem.Female patient.(b)(6).

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: GLOBAL SHD END PEG GLEN 44
• Type of Device: GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 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: 7709741
• MDR Text Key: 114672918
• Report Number: 1818910-2018-64927
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10603295007241
• UDI-Public: 10603295007241
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113785025
• Device Lot Number: Z2AA61000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2005
• 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: 67 YR