MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ANCHOR PLATE SIZE 44; SHOULDER HUMERAL STEM ACCESSORY

Catalog Number 114010044

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Muscle/Tendon Damage (4532)

Event Date 06/08/2020

Event Type  Injury  

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 Description

Clinical adverse event received for biceps tendonitis after tenodesis.Event is not serious and is considered mild.Event is possibly related to device and procedure.Date of implantation: (b)(6) 2019, date of event (onset): (b)(6) 2020, (right shoulder).Treatment: medical intervention/modification (details unspecified).

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 : dhr was reviewed.1.Quantity manufactured was (b)(4).2.Date of manufacture was 15-may-2018.3.No deviations or anomalies were observed.4.Expiry: 30-apr-2028.5.Ifu reference 090200874.

• Brand Name: ANCHOR PLATE SIZE 44
• Type of Device: SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12283088
• MDR Text Key: 265242360
• Report Number: 1818910-2021-17190
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295381105
• UDI-Public: 10603295381105
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114010044
• Device Lot Number: 8757579
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANCHOR PLATE SIZE 44; CROSSLINK ANCHOR PG GLENOID 40; HUMERAL HEAD SIZE 46; ANCHOR PLATE SIZE 44; CROSSLINK ANCHOR PG GLENOID 40; HUMERAL HEAD SIZE 46
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 73