MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER IMPLANT

Catalog Number UNK SHOULDER IMPLANT

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/07/2021

Event Type  Injury  

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 Description

The patient's shoulder was revised due to a worn out of the rotator cuff and is needed a reverse.Doi: unk, dor: (b)(6) 2021, left shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN SHOULDER IMPLANT
• Type of Device: SHOULDER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12565170
• MDR Text Key: 274439281
• Report Number: 1818910-2021-21762
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLOBAL ADVANTAGE CTA HD 48X18; GLOBAL ADVANTAGE PC STEM 8MM
• Patient Outcome(s): Required Intervention