MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND GLENOSPHERE ECC D42MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Catalog Number	130760042
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional 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 the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported the patient was revised due to painful right shoulder.It was noted the glenosphere appeared to be tilted from metaglene.The implants were removed and replaced.It was noted there was a possible infection in the shoulder and a possible break on the post at the bottom of glenosphere and piece in the metaglene post.Doi: (b)(6) 2019.Dor: (b)(6) 2025.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.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 recon described in this report.H11 additional narrative: added: d4 (lot, expiration date), d9, h4, h6 (health effect clinical code and medical device problem code).Corrected: d4 primary udi number.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # = >(b)(4) investigation summary = > patient was revised due to painful right shoulder.Originally implanted by doctor (b)(6) 2019.Doctor revised.Removed delta xtend metaglene, delta xtend pe cup, delta xtend glenosphere and four screws.Revised those implants.Possibly infected shoulder.Possible break on the post at the bottom of glenosphere and piece in the metaglene post.The product was returned to depuy synthes for evaluation.The complaint unit was forwarded was forwarded to the depuy synthes material science lab in warsaw for further evaluation.Visual analysis revealed that the glenosphere screw was fractured within the metaglene.Severe burnishing was observed on the fracture surfaces.Sem imaging of the fracture surface of the proximal fragment of the glenosphere screw retained within the metaglene showed isolated regions unobscured by burnishing with fatigue features.Fatigue striations and other features consistent with titanium fatigue were observed.All fracture features observed were indicative of low stress high cycle fatigue; however, the initiation site or region could not be determined due to extensive burnishing.No evidence of material or manufacturing defects was observed that could have contributed to fracture initiation and/or propagation to failure.Although a definitive cause for device fracture is not established, 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 manufacturing record evaluation was performed for the finished device (b)(6) number, and no non-conformances / manufacturing irregularities related to the complaint condition were identified.The overall complaint was confirmed as the observed condition of the dxtend glenosphere ecc d42mm would have contributed to the complained 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 depuy synthes 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 (b)(6) number, and no non-conformances / manufacturing irregularities related to the complaint condition were identified.Added: d10 (concomitant) corrected: h3, h4.

• Brand Name: DXTEND GLENOSPHERE ECC D42MM
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23935479
• Report Number: 1818910-2025-22871
• Device Sequence Number: 13129871
• Product Code: HSD
• UDI-Device Identifier: 10603295027751
• UDI-Public: (01)10603295027751(17)240630(10)5345274
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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: 06/30/2024
• Device Catalogue Number: 130760042
• Device Lot Number: 5345274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 04/20/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 01/07/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2019
• 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 METAGLENE; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND STAND PE CUP D42 +3MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male