MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND METAGLENE; DELTA XTEND IMPLANTS : SHOULDER METAGLENE

Model Number 130760000

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

Patient Problem Foreign Body Reaction (1868)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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

In 2015, the patient received a depuy right shoulder reverse prosthesis.The patient reports well-being until (b)(6) when a non-sore cyst occurs at the same shoulder level.The cyst was removed in (b)(6) 2018.Surgical indication is given at the orthopedic visit.On (b)(6) 2019, surgery is carried out to remove the depuy prosthesis and it will be replaced with another prosthesis from another supplier.Diagnosis at discharge is of depuy shoulder reverse prosthesis metallosis documented in medical records.Doi: (b)(6) 2015; dor: (b)(6) 2019; right shoulder.

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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: DXTEND METAGLENE
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER METAGLENE
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15121338
• MDR Text Key: 296769625
• Report Number: 1818910-2022-14303
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027737
• UDI-Public: 10603295027737
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 130760000
• Device Catalogue Number: 130760000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• 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: DXTEND METAGLENE; UNK SHOULDER GLENOSPHERE DELTA XTEND; UNK SHOULDER LOCKING SCREW; UNK SHOULDER LOCKING SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR