MAUDE Adverse Event Report: DEPUY IRELAND DXTEND GLENOSPHERE ECC D38MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Catalog Number	130760038
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reverse shoulder prosthesis was implanted in our hospital four years ago.Its function is excellent.A firm, elastic bulge has formed anteriorly in the area of the deltoideopectoral approach.Radiological examination on (b)(6) 2024, revealed a dislocation of the glenosphere relative to the metaglene.There is an indication for replacement of the glenosphere and, if necessary, also the metaglene in conjunction with an inlay replacement.The revision surgery took place on (b)(6) 2025.The procedure was completed with no issues noted.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: hcp is reporting to nca/bfarm: "the reverse shoulder prosthesis was implanted in our hospital four years ago.Its function is excellent.A firm, elastic bulge has formed anteriorly in the area of the deltoideopectoral approach.Radiological examination on (b)(6) 2024, revealed a dislocation of the glenosphere relative to the metaglene.There is an indication for replacement of the glenosphere and, if necessary, also the metaglene in conjunction with an inlay replacement.The planned surgery took place on (b)(6) 2025.The following findings were observed: (copy from the surgical report) ".This clears the path into the joint, and the articular membrane with severe metallosis is removed, both around the shaft and in the area of the glenosphere.This membrane has completely detached from the metaglene, but still articulates well with the shaft portion of the prosthesis.First, the glenosphere is removed, followed by the inlay.This provides even better access to the joint and allows the synovialectomy to continue.Only at the lower edge of the glenoid is one careful to avoid damaging the axillary nerve.Then, the screw residue of the glenosphere locking screw is exposed in the middle of the metaglene.Fortunately, it had a central hole that a conical male left-hand thread cutter engages.The metaglene is then cleanly freed of scar tissue all around, and a new 38 mm glenosphere is applied caudally with the eccentric tool.Fixed."intraoperatively, photo documentation done." the product was not returned to j&j medtech orthopaedics; however, a photo was provided for review.(b)(4) photo explant.The photo investigation revealed that a fractured occurred on the distal portion of the screw of the dxtend glenosphere ecc d38mm.No other damage was observed.Due to the fracture observed on the dxtend glenosphere ecc d38mm, it is reasonable to conclude that a disassociation event occurred between the glenosphere and the metaglene.A manufacturing record evaluation was performed for the finished device [130760038 / 5369802] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified.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.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the dxtend glenosphere ecc d38mm would have contributed 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: 1) quantity manufactured: (b)(4).2) date of manufacture: 10/14/2020.3) any anomalies or deviations identified in dhr: capa 2020-034 (viant) bounding linked to depuy's nr-0146283 (depuy).No correlation to the reported event was found.4) expiry date: 9/30/2025.5) ifu reference: ifu-w90930 rev.B.Device history review: a manufacturing record evaluation was performed for the finished device [130760038 / 5369802] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: DXTEND GLENOSPHERE ECC D38MM
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22136027
• Report Number: 1818910-2025-08962
• Device Sequence Number: 17977682
• Product Code: HSD
• UDI-Device Identifier: 10603295027744
• UDI-Public: (01)10603295027744(17)250930(10)5369802
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 09/30/2025
• Device Catalogue Number: 130760038
• Device Lot Number: 5369802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female