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

Catalog Number	130761142
Medical Device Problem Codes	Difficult to Insert (1316); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, 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.H11 additional narrative: d4: udi: as the catalog/model number was not provided, the (01) gtin is not available.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
It was reported that glenosphere (short screw) cannot be implanted.The glenosphere screw cannot be in metaglene hole.Short screw prevents view and feel option.Soft tissue fold is not visible.The patient experienced luxation of shoulder joint same day post op and required revision surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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 the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
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.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: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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: the device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
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: d9.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, ¿glenosphere (short screw) cannot be implanted glenosphere screw cannot be in metaglene hole.Short screw prevents view.Short screw prevents feel option.Soft tissue fold not visible¿ the product returned to medtech orthopaedics for evaluation.The medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned device revealed that the xtndgleno d42mm +0mm shrtpst was found cross-threaded from the driving recess and the initial threads of the screw.Additionally, the surface displays marks which are consistent with the implantation attempts.The observed damaged condition suggests that the glenosphere was not properly aligned with the metaglene and excessive or off-axis forces were applied.This would contribute to the difficulty/inability to mate the glenosphere with the mating component following multiple insertion attempts.As per delta xtend¿ reverse shoulder system surgical technique "proper alignment between the glenosphere and metaglene is absolutely essential to avoid cross threading between the components.Proper alignment leads to smooth thread engagement and easy screwing.If the glenosphere seems difficult to thread onto the metaglene, do not force engagement but re-align the components".A manufacturing record evaluation were performed for the finished device 130761142, lot number d24044557, it was manufactured on 28-apr-2024.(b)(4) parts were manufactured per specification and all raw materials met specification, and no non-conformances / manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the xtndgleno d42mm +0mm shrtpst would 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 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: a manufacturing record evaluation were performed for the finished device 130761142, lot number d24044557, it was manufactured on 28-apr-2024.(b)(4) pcs parts were manufactured per specification and all raw materials met specification, and no non-conformances / manufacturing irregularities were identified.Device history review : a manufacturing record evaluation were performed for the finished device 130761142, lot number d24044557, it was manufactured on 28-apr-2024.(b)(4) parts were manufactured per specification and all raw materials met specification, 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 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20914219
• Report Number: 1818910-2024-25275
• Device Sequence Number: 18261750
• Product Code: PHX
• UDI-Device Identifier: 10603295502562
• UDI-Public: (01)10603295502562(17)290331(10)D24044557
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,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 Catalogue Number: 130761142
• Device Lot Number: D24044557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 12/24/2024; 01/31/2025; 03/14/2025; 05/19/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 12/17/2024; 01/06/2025; 02/03/2025; 03/17/2025; 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2024
• 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 HUMERAL SPACER +9MM; DXTEND RETENT PE CUP D38 +6MM; UNKNOWN BASEPLATE INHANCE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown