MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 HUMERAL HEAD SIZE 44; SHOULDER HUMERAL HEADS

Catalog Number	114020044
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Anatomic total shoulder replacement, (b)(6) 2020; primary implant date: (b)(6) 2019; reason for revision: failure of fixation of the anchor peg glenoid component of a global icon anchor peg glenoid atsr (b)(6) 2020.Ct image and x-ray images available.Being revised to delta xtend rtsr.Patient activity levels; semi sedentary.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received stated that there was an implant loosening of the glenoid component.The implant was fully intact and well positioned.Loosening might have been related tot he suspected overstuffed nature of the joint.
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.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.

• Brand Name: HUMERAL HEAD SIZE 44
• Common Device Name: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10251640
• Report Number: 1818910-2020-15394
• Device Sequence Number: 470488
• Product Code: KWS
• UDI-Device Identifier: 10603295381235
• UDI-Public: 10603295381235
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 114020044
• Device Lot Number: HN6931
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 07/21/2020; 08/18/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/23/2020; 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANCHOR PLATE SIZE 42; CROSSLINK ANCHOR PG GLENOID 40; HUMERAL HEAD SIZE 44; ANCHOR PLATE SIZE 42; CROSSLINK ANCHOR PG GLENOID 40; HUMERAL HEAD SIZE 44
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR