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

Catalog Number	130760138
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that glenosphere was defective.Doe: (b)(6) 2024.Affected side: left shoulder.Additional event information: a.No delay.B.No adverse consequences.C.The man hole.Cover came off the back of the glenosphere and the security screw broke.D.Didn't happen during surgery.
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).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.H11 additional narrative: added: a1, a2, a3a, d10 concomitant.Corrected: h1 (type of reportable event), h6 (health effect - clinical code, health effect - impact code & medical device problem code).Updated pe code implant fracture intra-op metal to implant fracture post-op metal 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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that 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.H11 additional narrative: added : d9.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 according to the information received, ¿it was reported that glenosphere was defective.Doe: (b)(6) 2024.Affected side: left shoulder¿.The product returned to medtech orthopaedics for evaluation.The medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of revealed that dxtend glenosphere std d38mm was returned with the washer subcomponent and central screw disassembled.Additionally, the screw was found fractured at the distal section.Fracture surface of the screw shows evidence of low stress high cycle fatigue features, with a secondary crack formed proximal to the fracture.Fracture appears to be secondary to loosening of the glenosphere central screw with respect to the metaglene, as evidenced by the deformation and wear of the threads of the central screw.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.However, with the information provided is not possible to determine a potential cause at this moment.Nevertheless, in support of the evaluation performed, the observed damage of the dxtend glenosphere std d38mm may have been caused to the central screw not being sufficiently tightened during implantation.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A dimensional inspection and functional testing were not performed as it is not applicable to the complaint condition.A manufacturing record evaluation was performed for the finished device [product code: 130760138/ lot: 5248028] and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the dxtend glenosphere std d38mm would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a manufacturing record evaluation was performed for the finished device [product code: 130760138/ lot: 5248028] and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review a manufacturing record evaluation was performed for the finished device [product code: 130760138/ lot: 5248028] and no non-conformances / manufacturing irregularities were identified during manufacturing.H11 additional narrative: corrected: h3.

• Brand Name: DXTEND GLENOSPHERE STD D38MM
• Common Device Name: 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: 19916737
• Report Number: 1818910-2024-16836
• Device Sequence Number: 8095066
• Product Code: HSD
• UDI-Device Identifier: 10603295027768
• UDI-Public: (01)10603295027768(17)200201(10)5248028
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 08/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: 130760138
• Device Lot Number: 5248028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 08/06/2024; 08/22/2024; 03/31/2025
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 08/09/2024; 08/23/2024; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2015
• 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 NO LOCK D4.5X18MM.; DXTEND STAND PE CUP D38 +3MM.
• Patient Age: 80 YR
• Patient Sex: Female