MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DXTEND GLENOSPHERE ECC D42MM; JRN : SHOULDER GLENOSPHERE

Catalog Number	130760042
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the central screw on glenosphere broke and dislocated from implant construct.It was replaced , as well as, one of the screws and the poly.The glenosphere was dislocated from the implant construct.Glenosphere was replaced, as was one of the screws and the poly.Doi: (b)(6) 2019.Dor: (b)(6) 2023.Affected side: right shoulder.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A manufacturing record evaluation (nc search) was performed for the finished device product code:130760042, lot - 5328080, and no non-conformances / manufacturing irregularities were identified 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.If additional information is made available, the investigation will be updated as applicable.Device history lot : a manufacturing record evaluation (nc search) was performed for the finished device product code:130760042, lot - 5328080, and no non-conformances / manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: a.Please clarify, was the glenosphere fractured? no.B.Was there any suggestion by anyone indicating that there was or may be a deficiency with the dxtend screw lock d4.5x36mm? if yes, please provide details.Possibly wasn't seated all the way.

• Brand Name: DXTEND GLENOSPHERE ECC D42MM
• Common Device Name: JRN : 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 ; 3035526892
• MDR Report Key: 18182566
• Report Number: 1818910-2023-23798
• Device Sequence Number: 15366870
• Product Code: HSD
• UDI-Device Identifier: 10603295027751
• UDI-Public: 10603295027751
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 130760042
• Device Lot Number: 5328080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 12/01/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 11/29/2023; 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DXTEND SCREW LOCK D4.5X36MM; DXTEND STAND PE CUP D42 +6MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male