MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL SPACER

Catalog Number UNK SHOULDER HUMERAL SPACER

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

Patient Problem Joint Laxity (4526)

Event Date 03/03/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Component code: appropriate term/code not available (g07002) used to capture no findings available.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.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.

Event Description

Patient was revised due to instability of post reverse shoulder left.Doi: unknown.Dor: on (b)(6) 2023.Affected side: left shoulder.

• Brand Name: UNKNOWN SHOULDER HUMERAL SPACER
• Type of Device: SHOULDER HUMERAL SPACER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16597554
• MDR Text Key: 311832904
• Report Number: 1818910-2023-06444
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL SPACER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 38+3 DELTA POLY.; UNKNOWN SHOULDER HUMERAL SPACER.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 112 KG