MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND MBLOC HUM EPI 1 D8 STD; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	130708100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Additional narrative: a2: patient date of birth is an unknown date in 1951.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
Revision of monobloc epiphysis (left side) because of fracture.Patient fell during their inpatient stay and suffered a prosthesis shaft fracture with an implanted reverse shoulder prosthesis on the left, without any apparent bone trauma.
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 hat 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 d4 (expiration date), d4 (lot), d9.Corrected d4 (primary udi).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: d10.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 provided: "revision of monobloc epiphysis left side because of fracture", "the insured person fell during his inpatient stay at the 360 grad specialist clinic in ratingen on the ward level and suffered a prosthesis shaft fracture with an implanted reverse shoulder prosthesis on the left, without any apparent bone trauma" and "explant is not possible to be investigated at the moment as patient was discharged from the hospital before he could sign the patient consent to investigate explants.Anyhow, they try to get the requested signature".The product was not returned to depuy synthes, however, photos were provided for review.See attachment ((b)(4) x-ray pre-revision and (b)(4) about 2019 implant passport).The photo/x-ray investigation revealed the body of the stem fractured, confirming the reporting event.No other anomaly was identified on the evidence provided.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and 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.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.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the dxtend mbloc hum epi 1 d8 std 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 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.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.Added: b5.
Event or Problem Description
Additional information received: explant is not possible to be investigated at the moment as patient was discharged from the hospital before he could sign the patient consent to investigate explants.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > according to the information provided: "revision of monobloc epiphysis left side because of fracture", "the insured person fell during his inpatient stay at the 360 grad specialist clinic in ratingen on the ward level and suffered a prosthesis shaft fracture with an implanted reverse shoulder prosthesis on the left, without any apparent bone trauma" and "explant is not possible to be investigated at the moment as patient was discharged from the hospital before he could sign the patient consent to investigate explants.Anyhow, they try to get the requested signature".The product was not returned to depuy synthes, however photos were provided for review.See attachment ((b)(4) x-ray pre-revision and (b)(4) about 2019 implant passport).The photo/x-ray investigation revealed the body of the stem fractured, confirming the reporting event.No other anomaly was identified on the evidence provided.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and 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.A manufacturing record evaluation was performed for the finished device 130708100/ 5221647 number, and no non-conformances or manufacturing irregularities related to the complaint condition were identified.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the dxtend mbloc hum epi 1 d8 std 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 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.Device history lot = > 1) quantity manufactured: (b)(4).2) date of manufacture: 01/2014.3) any anomalies or deviations identified in dhr: none.4) expiry date: 12/2018.5) ifu reference: ifu w90930.Device history review = > a manufacturing record evaluation was performed for the finished device 130708100/ 5221647 number, and no non-conformances or manufacturing irregularities related to the complaint condition were identified.Added: d10, h4.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary revision of monobloc epiphysis left side because of fracture.The product was returned to depuy synthes for evaluation.Visual inspection reveled that the dxtend mbloc hum epi 1 d8 std was fractured at the middle section.Fractured pieces were returned for evaluation.The fracture surfaces are severely damaged, features consistent with low stress high cycle fatigue fracture.The damage of the outer stem surface immediately adjacent the fracture appears consistent with retrieval damage, however it cannot be conclusively determined.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and 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.It is highly recommended to the patient to consult with their healthcare professional for further assessment.A manufacturing record evaluation was performed for the finished device 130708100/ 5221647 number, and no non-conformances or manufacturing irregularities related to the complaint condition were identified.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the dxtend mbloc hum epi 1 d8 std 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 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.Device history lot 1) quantity manufactured: (b)(4) 2) date of manufacture: 01/2014 3) any anomalies or deviations identified in dhr: none 4) expiry date: 12/2018 5) ifu reference: ifu w90930.Device history review a manufacturing record evaluation was performed for the finished device 130708100/ 5221647 number, and no non-conformances or manufacturing irregularities related to the complaint condition were identified.H11 additional narrative: corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided: "revision of monobloc epiphysis left side because of fracture", "the insured person fell during his inpatient stay at the 360 grad specialist clinic in ratingen on the ward level and suffered a prosthesis shaft fracture with an implanted reverse shoulder prosthesis on the left, without any apparent bone trauma" and "explant is not possible to be investigated at the moment as patient was discharged from the hospital before he could sign the patient consent to investigate explants.Anyhow, they try to get the requested signature".The product was not returned to depuy synthes; however, photos were provided for review.((b)(4) x-ray pre-revision and (b)(4) about 2019 implant passport).The photo/x-ray investigation revealed the body of the stem fractured, confirming the reporting event.No other anomaly was identified on the evidence provided.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and 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.A manufacturing record evaluation was performed for the finished device 130708100/ 5221647 number, and no non-conformances or manufacturing irregularities related to the complaint condition were identified.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the dxtend mbloc hum epi 1 d8 std 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 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.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 01/2014.3) any anomalies or deviations identified in dhr: none.4) expiry date: 12/2018.5) ifu reference: ifu w90930.Device history review: a manufacturing record evaluation was performed for the finished device 130708100/ 5221647 number, and no non-conformances or manufacturing irregularities related to the complaint condition were identified.

• Brand Name: DXTEND MBLOC HUM EPI 1 D8 STD
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
• 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: 23555116
• Report Number: 1818910-2025-19837
• Device Sequence Number: 9764329
• Product Code: KWS
• UDI-Device Identifier: 10603295027102
• UDI-Public: (01)10603295027102(17)181201(10)5221647
• 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,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 Expiration Date: 12/01/2018
• Device Catalogue Number: 130708100
• Device Lot Number: 5221647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 01/06/2026; 01/21/2026; 01/23/2026; 01/26/2026; 01/26/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 11/25/2025; 01/07/2026; 01/22/2026; 01/26/2026; 01/27/2026; 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2014
• 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 MBLOC HUM EPI 1 D8 STD.; DXTEND STAND PE CUP D42 +9MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male