MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL ADVANTAGE ECC HD 44X21; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS

Catalog Number	112844120
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 s-fit and global advantage shoulder replacement, (b)(6) private (b)(6) 2018.Primary implant date: (b)(6) 2004.S-fit glenoid use with global advantage stem for anatomical shoulder replacement 14 years ago.Patient experienced pain onset and was advised to revise due to rotator cuff deficiency.There was poly wear and glenoid wear to the point where there was metal on metal with the prosthesis.Revised all implants, with delta xtend reverse shoulder.Relevant patient pre-existing conditions/ comorbidities: rotator cuff deficiency.Patient initial (b)(6).Unknown jrn: (b)(4) s-fit glenoid bearing 44x3 lot # 1141284; unknown jrn: (b)(4) s-fit mb glenoid 44mm lot # ymv-40; unknown jrn: no product code - 3.5x28 screws for s-fit - lot # unknown.
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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: GLOBAL ADVANTAGE ECC HD 44X21
• Common Device Name: GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7596620
• Report Number: 1818910-2018-62079
• Device Sequence Number: 1186836
• Product Code: HSD
• UDI-Device Identifier: 10603295005131
• UDI-Public: 10603295005131
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K992065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 112844120
• Device Lot Number: VY7GL1024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 12/03/2018
• 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: 80 YR