MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DXTEND STAND PE CUP D42 +6MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Catalog Number	130742206
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.
Event or Problem Description
It was reported that intraoperatively during primary surgery it was not possible to engage the inlay with the metaphysis.Another inlay was used without issues.Surgical delay about two minutes.No adverse patient consequences.
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 corrected: d4 primary udi number 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: h4.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, ¿intraoperatively during primary surgery it was not possible to engange the inlay with the metaphysis.Another inlay was used without issues.Surgical delay about two minutes.No adverse patient consequences¿.The product returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that dxtend stand pe cup d42 +6mm does not exhibits sings of damage nor evidence of a device non-conformance that could have contributed to the reported event.Light marks were observed at the bottom surface, consistent with the reported assembly attempts.Refer to the delta xtend¿ reverse shoulder system surgical technique (103333) section "final cup fixation" for the proper assembly of the polyethylene humeral cup.A dimensional inspection was performed for the dxtend stand pe cup d42 +6mm and met specifications.However, a functional test was not performed since the reported mating device was not returned for evaluation.A manufacturing record evaluation was performed for the finished device [130742206 / 5624585] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was not confirmed as the observed condition of the dxtend stand pe cup d42 +6mm would not 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 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.Drawing/specifications reviewed? dwg-8e070155 rev d (current and manufactured) specified dimensions: major ø = 42.00mm +/- 0.15mm total height= 18.9mm +/- 0.2mm width of the upper section= 9.15mm + 0.2mm measured dimensions: major ø = 41.94mm (complies) total height= 18.84mm (complies) width of the upper section= 9.21 mm (complies) device used ¿ digimatic caliper cd78622 device history lot = > 1) quantity manufactured: 50 2) date of manufacture: 15-nov-2023 3) any anomalies or deviations identified in dhr: none 4) expiry date: 31-oct-2028 5) ifu reference: w90930 rev d device history batch null device history review a manufacturing record evaluation was performed for the finished device [130742206 / 5624585] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: DXTEND STAND PE CUP D42 +6MM
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19859812
• Report Number: 1818910-2024-16283
• Device Sequence Number: 8103083
• Product Code: HSD
• UDI-Device Identifier: 10603295027546
• UDI-Public: (01)10603295027546(10)5624585
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/30/2024

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 Catalogue Number: 130742206
• Device Lot Number: 5624585
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 08/07/2024; 10/03/2024; 10/14/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 08/08/2024; 10/08/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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
• Patient Sex: Unknown