MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US XTNDGLENO D42MM +0MM SHRTPST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	130761142
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
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.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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 intraoperative it was not possible to engage three glenosphere with the the metaglene.In the end the metaglene was also replaced, as it was it was not clear why the connection had failed.No adverse patient consequences reported.To complete the surgery a glenosphere 42+4 was implanted.There was no surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.According to the information received, ¿intraoperative it was not possible to engage the glenosphere with the the metaglene.Three glenosheres did not engange with the metaglene.In the end the metaglene was also replaced, as it was it was not clear why the connection had failed.No adverse patient consequences reported.To complete the surgery a glenosphere 42+4 was implanted." product description: xtndgleno d42mm +0mm shrtpst, product code: 130761142, lot number: d24073749, quantity manufactured: (b)(4), date of manufacture: 02-aug-2024, expiry date: 31-jul-2029, ifu reference: (b)(4).As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: product description: xtndgleno d42mm +0mm shrtpst, product code: 130761142, lot number: d24073749, quantity manufactured: (b)(4), date of manufacture: 02-aug-2024, expiry date: 31-jul-2029, ifu reference: (b)(4).Device history review: a manufacturing record evaluation were performed for the finished device 130761142, lot number d24073749, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: XTNDGLENO D42MM +0MM SHRTPST
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21044041
• Report Number: 1818910-2024-26159
• Device Sequence Number: 7573679
• Product Code: PHX
• UDI-Device Identifier: 10603295502562
• UDI-Public: (01)10603295502562
• 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

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: 130761142
• Device Lot Number: D24073749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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