MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND SCREW NO LOCK D4.5X36MM; DELTA XTEND IMPLANTS : SCREWS

Catalog Number	130770036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Unspecified Tissue Injury (4559)
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.
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).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.See attachment (b)(4) photo explant.The photograph attached was reviewed, however it does not represent the reported product complaint.Therefore, the investigation could not draw any conclusions about the reported product due to the insufficient evidence provided.A manufacturing record evaluation was performed for the finished device [130770036 / 5363462], and no non-conformances or manufacturing irregularities were identified.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 not confirmed as the photographs provided are not representative of the reported product and adverse event.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: 3/25/2020.3) any anomalies or deviations identified in dhr: none.4) expiry date: 2/28/2025.5) ifu reference: w90930 rev b.Device history review = > a manufacturing record evaluation was performed for the finished device [130770036 / 5363462], and no non-conformances or manufacturing irregularities were identified.

• Brand Name: DXTEND SCREW NO LOCK D4.5X36MM
• Common Device Name: DELTA XTEND IMPLANTS : SCREWS
• 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: 22136047
• Report Number: 1818910-2025-08965
• Device Sequence Number: 20671940
• Product Code: HSD
• UDI-Device Identifier: 10603295027812
• UDI-Public: (01)10603295027812(17)250228(10)5363462
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 130770036
• Device Lot Number: 5363462
• 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: 03/23/2020
• 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