MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US XTNDGLENO D42MM +0MM SHRTPST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 130761142

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

Patient Problems Pain (1994); Joint Laxity (4526)

Event Type  Injury  

Event Description

A depuy synthes implant was revised and reviewed for analysis reason for revision: instability & pain.

Manufacturer Narrative

Product complaint # (b)(4).B3: date of event is an unknown date.H6 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.A manufacturing record evaluation (nc search) was performed for the finished device product code: 130761142, lot - d19080713 and no non-conformances / manufacturing irregularities were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device product code: 130761142, lot - d19080713 and no non-conformances / manufacturing irregularities were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

• Brand Name: XTNDGLENO D42MM +0MM SHRTPST
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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 ; 3035526892
• MDR Report Key: 18961862
• MDR Text Key: 338386805
• Report Number: 1818910-2024-06391
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295502562
• UDI-Public: 10603295502562
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 130761142
• Device Lot Number: D19080713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2019
• 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: DXTEND STAND PE CUP D42 +3MM
• Patient Outcome(s): Required Intervention