MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DXTEND GLENOSPHERE STD D38MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Catalog Number 130760138

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Unspecified Mental, Emotional or Behavioural Problem (4430); Joint Laxity (4526)

Event Date 07/28/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # :(b)(6).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.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.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 right reverse shoulder replacement: primary surgery completed.Patient became confused overnight, took off sling and tried to get up, dislocating shoulder.Surgeon attempted closed reduction but could feel shoulder would continue to pop out.Suspected a thicker poly could be used for more soft tissue tension and boney impingement.On x-ray some inferior bone could be seen that was not removed by surgeon, potentially causing the shoulder to impinge and dislocate.Went back in, removed the bone, switched to a larger and eccentric glensophere to provide more inferior offset and a thicker poly.Shoulder was no longer dislocating.Doi: (b)(6) 2023.Doe: (b)(6) 2023.Affected side: right.

• Brand Name: DXTEND GLENOSPHERE STD D38MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17540514
• MDR Text Key: 321062153
• Report Number: 1818910-2023-16666
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027768
• UDI-Public: 10603295027768
• 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
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130760138
• Device Lot Number: 5413144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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 STAND PE CUP D38 +3MM
• Patient Outcome(s): Required Intervention