MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DXTEND SCREW NO LOCK D4.5X18MM; DELTA XTEND IMPLANTS : SCREWS

Model Number 130770018

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

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 05/03/2023

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

Revision of left reverse shoulder replacement for suspected infection - patient experiencing pain and signs of loosening on x-ray.Test results showed elevated levels indicating potential infection.Open samples were taken, pus was found.All implants removed.Surgeon flushed and treated the area and put in an antibiotic spacer.Will come back for 2nd stage revision once infection cleared.Doi: (b)(6) 2020.Dor: (b)(6) 2023.Left shoulder.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the photographic evidence found nothing indicative of a device nonconformance or a relation with the reported adverse event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DXTEND SCREW NO LOCK D4.5X18MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16933660
• MDR Text Key: 315236368
• Report Number: 1818910-2023-10235
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027782
• UDI-Public: 10603295027782
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K192855
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 130770018
• Device Catalogue Number: 130770018
• Device Lot Number: 5366614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• 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: DXTEND GLENOSPHERE STD D42MM; DXTEND METAGLENE; DXTEND MOD EPI 2 ECC LEFT HA; DXTEND MODULAR HUM STEM D12 HA; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW LOCK D4.5X42MM; DXTEND STAND PE CUP D42 +3MM
• Patient Outcome(s): Required Intervention