MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ANCHOR PLATE SIZE 50; SHOULDER HUMERAL STEM ACCESSORY

Model Number 1140-10-050

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

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2020

Event Type  Injury  

Event Description

Clinical adverse event received for foraminotomy surgery (not for the study shoulder) event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2019.Date of event: (b)(6) 2020 (right shoulder).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).The complaint database has been updated to state that the adverse event "foraminotomy surgery (not for the study shoulder)" is no longer is possibly related to device or procedure, but has been changed to definitely not related to device or to procedure.Per clinical process, this now indicates that this adverse event no longer meets the definition of a medical device complaint.The adverse event is unrelated to device or procedure, and therefore, there is no contribution by depuy products or procedure towards the adverse event.Clinical database now indicates ae is not related to device or procedure.As a consequence, this complaint will be downgraded and moved to an npi status.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ANCHOR PLATE SIZE 50
• Type of Device: SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14753025
• MDR Text Key: 294390726
• Report Number: 1818910-2022-11309
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 10603295381136
• UDI-Public: 10603295381136
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K212683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2022

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
• Device Operator: Health Professional
• Device Model Number: 1140-10-050
• Device Catalogue Number: 114010050
• Device Lot Number: 8708208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 07/06/2022; 07/13/2022
• Supplement Dates FDA Received: 07/07/2022; 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANCHOR PLATE SIZE 50; CROSSLINK ANCHOR PG GLENOID 48; HUMERAL HEAD SIZE 50
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 87 KG