MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ACTIS COLLARED HIGH SIZE 9; HIP FEMORAL STEM

Catalog Number	101012090
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
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.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
According to the surgeon the stem was implanted in (b)(6) 2022 in brig by surgeon, he had to change it due to a malrotation, not an implant failure.Doi: (b)(6 2022, doe: (b)(6) 2023.
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 : according to the surgeon the stem was implanted in (b)(6) 2022 in brig by surgeon, he had to change it due to a malrotation, not an implant failure.The product was not returned to depuy synthes, however radiographs were provided for review.See attachment "(b)(4)".Review of the radiographs evidence found nothing indicative of a device nonconformance with the actis collared std sz 9.In order to confirm the reported migration of the femoral stem more evidence is required.The overall complaint was unconfirmed as the observed condition of the actis collared std sz 9 would not contribute to the complained 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 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the surgeon the stem was implanted in (b)(6) 2022 in brig by surgeon, he had to change it due to a malrotation, not an implant failure the device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned actis collared std sz 9 found no defects that could have contributed to the reported event.The returned sample was found with bone residue.The allegation cannot be confirmed.A dimensional inspection for the actis collared std sz 9 was not performed as it is not applicable to the complaint condition.The overall complaint was unconfirmed as the observed condition of the actis collared std sz 9 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.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).Investigation summary - according to the surgeon the stem was implanted in (b)(6) 2022 in brig by surgeon, he had to change it due to a malrotation, not an implant failure.The product was not returned to depuy synthes, however radiographs were provided for review.See attachment "9.10.23 insel2.Jpg and 9.10.23 insel.Jpg".Review of the radiographs evidence found nothing indicative of a device nonconformance with the actis collared high size 9.In order to confirm the reported migration of the femoral stem more evidence is required.The overall complaint was unconfirmed as the observed condition of the actis collared high size 9 would not contribute to the complained 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 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the surgeon the stem was implanted in (b)(6) 2022 in brig by surgeon, he had to change it due to a malrotation, not an implant failure.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned actis collared std sz 9 found no defects that could have contributed to the reported event.The returned sample was found with bone residue.The allegation cannot be confirmed.The lot # is not visible as the actis collared std sz 9 is assembled with the delta cer head.A dimensional inspection for the actis collared std sz 9 was not performed as it is not applicable to the complaint condition.The overall complaint was unconfirmed as the observed condition of the actis collared std sz 9 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.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.

• Brand Name: ACTIS COLLARED HIGH SIZE 9
• Common Device Name: HIP FEMORAL STEM
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17959566
• Report Number: 1818910-2023-21304
• Device Sequence Number: 7468372
• Product Code: MEH
• UDI-Device Identifier: 10603295380610
• UDI-Public: 10603295380610
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K202472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 10/18/2023
• 2 Devices were Involved in the Event: 1 2

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: 101012090
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 11/09/2023; 11/30/2023; 01/12/2024; 02/01/2024; 02/21/2024; 02/22/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/09/2023; 11/30/2023; 01/15/2024; 02/05/2024; 02/22/2024; 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: DELTA CER HEAD 12/14 36MM +5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male