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
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Additional 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
• Common Device Name: GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7709741
• Report Number: 1818910-2018-64927
• Device Sequence Number: 849009
• Product Code: KWT
• UDI-Device Identifier: 10603295007241
• UDI-Public: 10603295007241
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 113785025
• Device Lot Number: Z2AA61000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR