MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DXTEND GLENOSPHERE STD D38MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Model Number 130760138

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

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that this was a primary surgery performed for reverse shoulder with delta xtend on unknown date in 2022.On (b)(6), the surgeon reported that infection was suspected via email.On (b)(6), a revision surgery was performed, and the implant was replaced.We went attention to the sales rep to comply with the prescribed reporting date.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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.

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: 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 GLENOSPHERE STD D38MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 16830965
• MDR Text Key: 314162263
• Report Number: 1818910-2023-08943
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027768
• UDI-Public: 10603295027768
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 130760138
• Device Catalogue Number: 130760138
• Device Lot Number: 5390615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• 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 D38MM; DXTEND METAGLENE; DXTEND MOD EPI 1 ECC RIGHT HA; DXTEND MODULAR HUM STEM D14 HA; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND STAND PE CUP D38 +6MM; UNK SHOULDER GLENOSPHERE DELTA XTEND; UNK SHOULDER HUMERAL CUP DELTA XTEND; UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND; UNK SHOULDER HUMERAL STEM DELTA XTEND; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE
• Patient Outcome(s): Required Intervention