MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 HUMERAL HEAD SIZE 54; SHOULDER HUMERAL HEADS

Catalog Number	114020054
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	05/23/2019
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
Clinical adverse event received for silent inferior myocardial infarction event is not serious and is considered moderate event: there is a remote possibility that it is related to both device and procedure.Date of implantation:(b)(6) 2018.Date of event (onset): (b)(6) 2019.(left shoulder).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HUMERAL HEAD SIZE 54
• Common Device Name: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9155958
• Report Number: 1818910-2019-107750
• Device Sequence Number: 14314608
• Product Code: KWS
• UDI-Device Identifier: 10603295381280
• UDI-Public: 10603295381280
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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: 114020054
• Device Lot Number: HH6750
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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: 77 YR
• Patient Weight: 172