MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL AP HUMERAL STEM 10MM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS

Model Number 1130-10-000

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

Patient Problems Fall (1848); Unspecified Infection (1930); Pain (1994)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Please note, possible loosening is indicated within the initial report.Insufficient information is available to determine if / what products were loose.If further information becomes available, it will be processed and reported appropriately at that time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Atsr: (b)(6), (b)(6) 2019.The patient had a right global ap and anchor peg glenoid atsr on (b)(6) 2019.Pt had normal post-op recovery and early rehab.Post-op trauma with significant fall 1-month post-op.Painful since.No fractures or obvious disruption of components.Good range of movement, but the pain persisted.Investigated for infection, some p acne? scanned and hot spots both glenoid and proximal humerus.The arthroscopic investigation,? loose.Revised to delta xtend rtsr today.Anchor peg glenoid component had no evidence of osteointegration and was relatively easy to remove.Global ap components appeared well fixed.Normal post-op recovery expected.No ae reported, no delay in the surgery.Male patient, initials: (b)(6)., active and healthy pt, relevant patient pre-existing conditions: previous global ap and anchor peg glenoid atsr left side, functioning well.X-ray and ct are available.

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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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: GLOBAL AP HUMERAL STEM 10MM
• Type of Device: GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9459956
• MDR Text Key: 185511354
• Report Number: 1818910-2019-122829
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295005490
• UDI-Public: 10603295005490
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1130-10-000
• Device Catalogue Number: 113010000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention