MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND SCREW LOCK D4.5X24MM; DELTA XTEND IMPLANTS : SCREWS

Model Number 130790024

Device Problem Osseointegration Problem (3003)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646)

Event Date 06/06/2022

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

It was reported that the patient had loosening of the metaglene due to infection.Cement manufacturer was unknown.There was no surgical delay.Doi: unknown; dor: (b)(6) 2022; affected side: unknown shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

• Brand Name: DXTEND SCREW LOCK D4.5X24MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14743266
• MDR Text Key: 294937700
• Report Number: 1818910-2022-11242
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295027836
• UDI-Public: 10603295027836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120174
• 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,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130790024
• Device Catalogue Number: 130790024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• 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 SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X42MM.; GLENOSPHERE ECCENTRIC +0 42MM.; GLOBAL UNITE SZ 12 STANDARD STEM.; HUMERAL PE CUP SZ 42 +3.; METAGLENE.; SZ 1 CENTERED EPIPHYSIS..
• Patient Outcome(s): Required Intervention