MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 0; JRN : HIP FEMORAL STEM

Catalog Number	101012005
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/20/2023
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
It was reported that patient was revised due to loosening.The stem was easily removed and there was no ingrowth on stem.A c-stem was implanted.Doi: (b)(6) 2023 dor: 20 nov 2023 unk.Hip.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing: yes, did the patient require revision surgery or hardware removal? yes, facility name of original implant: (b)(6) hospital, was device explanted? true, hardware/explant removal due to: loosening, did patient require revision surgery? true, if yes, date of revision surgery.11/20/2023, reason for revision surgery.The stem was loose, patient status/ outcome / consequences: yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, is the patient part of a clinical study: no, (b)(4).Device property of: patient, device in possession of: g maree.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst: true.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform 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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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.H10 additional narrative: 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
There was no surgical delay.It was a scheduled revision case.There was no harm to the patient except that she had to come back for the revision there was loosening on the stem/ femoral canal interface no cement was used i gave it to the warehouse for sending on the (b)(6) 2023.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: i was asked to book a c-stem for a revision of an actis that was loose.The initial date of operation was the 8 june 2023.The stem came out very easily and when looking at the stem there was no ingrowth on the stem.We implanted a c-stem.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned actis collared high size 0 found no defects that could have contributed to the reported event.The returned sample was found to have a slight amount of what appears to be bone on the fixation surface of the device, however, it must be considered that the short time the device was implanted may contribute to the observed condition.Based on the information provided, it is not possible to confirm the allegation.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was unconfirmed as the observed condition of the actis collared high size 0 would not 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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: d4 (primary udi number) and h3.
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.

• Brand Name: ACTIS COLLARED HIGH SIZE 0
• Common Device Name: JRN : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18256886
• Report Number: 1818910-2023-24497
• Device Sequence Number: 20630802
• Product Code: MEH
• UDI-Device Identifier: 10603295380528
• UDI-Public: (01)10603295380528(17)320131(10)JP7466
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K202472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/04/2023

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: 101012005
• Device Lot Number: JP7466
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 01/22/2024; 03/05/2024; 06/24/2024; 11/11/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/23/2024; 03/06/2024; 06/25/2024; 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female