MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL ADVANTAGE HUM HD 48X18; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS

Model Number 1128-48-010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).(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

Patient presented in clinic with painful right shoulder surgeon had replaced in (b)(6) 2003 at (b)(6) hospital.Patient also exhibited loss of function in right shoulder so the doctor elected to perform a revision surgery on patient¿s right shoulder.Performed revision surgery on (b)(6) 2019 at (b)(6) hospital.Surgeon removed the glenoid, humeral stem, and humeral head with instrumentation.He then elected to implant a reverse shoulder prosthesis using competitive systems.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint (b)(4).Investigation summary: the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.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 ADVANTAGE HUM HD 48X18
• Type of Device: GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9519671
• MDR Text Key: 185194340
• Report Number: 1818910-2019-124628
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295005155
• UDI-Public: 10603295005155
• Combination Product (y/n): N
• PMA/PMN Number: K984541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1128-48-010
• Device Catalogue Number: 112848010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 59