MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL UNITE BODY SZ 10 +5; SHOULDER BODY

Catalog Number	110030120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Patient was revised to address infection and loosening of the unknown component at bone to cement interface, depuy cement was used.
Additional Manufacturer Narrative
(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 UNITE BODY SZ 10 +5
• Common Device Name: SHOULDER BODY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7084648
• Report Number: 1818910-2017-50822
• Device Sequence Number: 1156595
• Product Code: HSD
• UDI-Device Identifier: 10603295004400
• UDI-Public: 10603295004400
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K101996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2017

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: 110030120
• Device Lot Number: 7225948
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 10/09/2018
• 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: 63 YR
• Patient Weight: 104