MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C STEM AMT LONG 2 STD OFFSET; C-STEM AMT LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

Catalog Number 157024087

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Death (1802); Not Applicable (3189); No Code Available (3191)

Event Date 07/20/2020

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).Us fda ra rationale: the stem and identified depuy cement are being reported as a death at this time.Follow-up was conducted regarding if a cement centralizer and restrictor were used and if so, which brand.No further information was provided at that time.It is reasonable to conclude the cup and head that were implanted did not contribute to the death that occurred.This was discussed and agreed upon by the medical safety officer.If further information is provided, the complaint will be updated as such.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The primary surgery was performed on an unknown date via bha with competitor stem.It was reported that the revision surgery was performed on (b)(6) 2020 by replacing competitor stem with the stem (p/n: 157024087) due to a fracture around competitor stem.The revision surgery was progress without any problem, the surgeon removed competitor stem smoothly, then, he reamed and rasped, inserted trial stem.The surgeon judged that there was no problem at that time, he implanted a restrictor, injected a cement and inserted the stem.After cement was cured, the surgeon implanted a head and a cup.But, after that, when he replanted crushed bone chip around proximal calcar, the patient¿s saturation dropped and the patient had arrest of the heart.The surgeon performed cardiac compression; the patient once recovered.The revision surgery transitioned the operation for searching thrombus.On (b)(6) 2020, the patient died.No further information is available.

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:  removed not applicable code and replaced with no code available (3191) to capture surgery.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Corrected: h6 (patient).

• Brand Name: C STEM AMT LONG 2 STD OFFSET
• Type of Device: C-STEM AMT LINE EXTENSION IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10364633
• MDR Text Key: 201610063
• Report Number: 1818910-2020-17553
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K042959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/19/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 157024087
• Device Lot Number: D18033608
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 07/19/2020; 08/28/2020; 01/07/2021
• Supplement Dates FDA Received: 08/07/2020; 08/31/2020; 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD; VMP ENDURANCE 80G; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD; VMP ENDURANCE 80G
• Patient Outcome(s): Death; Required Intervention