MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 HUMERAL HEAD SIZE 48; SHOULDER HUMERAL HEADS

Catalog Number 114020348

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

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Clinical symptoms code: appropriate term/code not available (e2402) used to capture infections.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.717.

Event Description

Revision of a global icon due to pain.All depuy synthes products were removed.When the components were removed it looked like the patient may have had an infection.Tissue samples were taken.Primary surgery was done on (b)(6) 2018.Competitor products were then implanted.

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 Description

Additional information received indicated that the patient did not have an infection.The reason for revision was loosening.

• Brand Name: HUMERAL HEAD SIZE 48
• Type of Device: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11003813
• MDR Text Key: 221537427
• Report Number: 1818910-2020-26876
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295451594
• UDI-Public: 10603295451594
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114020348
• Device Lot Number: HM5770
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 11/25/2020; 02/09/2021
• Supplement Dates FDA Received: 12/18/2020; 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANCHOR PLATE SIZE 48.; CROSSLINK ANCHOR PG GLENOID 44.; HUMERAL HEAD SIZE 48 +3.
• Patient Outcome(s): Required Intervention