MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSETGMV ENDURANCE GENT 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3105040

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

Patient Problems Cardiac Arrest (1762); Hypersensitivity/Allergic reaction (1907); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/16/2020

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Can you confirm the primary surgery date or the original implantation date? what is the affected side involved in this event? is there is a documented allergy pre-op to gentamycin antibiotic (included in the bone cement), or to methyl-methacrylate? did the crisis occur in the operating room, and then eventually resolved during the emergency response, which unfortunately resulted in the patient's death in the icu? is it possible that this was bone cement implantation syndrome? please provide patient initials.No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pot-op allergy.It was reported that after hip replacement operation (the implants are not jnj¿s, only used jnj's cement), the patient with allergic reaction, cardiac systolic function inhibition, hypotension and cardiac arrest.During the emergency rescue in icu, the patient was dead.

Event Description

A.What is the affected side involved in this event? answer: left side.B.Is there is a documented allergy pre-op to gentamycin antibiotic (included in the bone cement), or to methyl-methacrylate? answer: unknown.C.Did the crisis occur in the operating room, and then eventually resolved during the emergency response, which unfortunately resulted in the patient's death in the icu? answer: occur in the operation room.After implant cement,during solidification,noted allergy.E.Is it possible that this was bone cement implantation syndrome? answer: the surgeon said it is possible.

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: details for gentamicin component of combination product: dmf# - 13704, trade name ¿ gentamicin sulphate, active ingredient(s) ¿ gentamicin sulphate, dosage form - powder, strength ¿ 1.0g active in our cements.Added: a2 (age), b5 and d6a.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the complaint states: ¿pot-op allergy.It was reported that after hip replacement operation (the implants are not jnj¿s, only used jnj's cement), the patient with allergic reaction, cardiac systolic function inhibition, hypotension and cardiac arrest.During the emergency rescue in icu, the patient was dead.¿ retained sample retest results: retained powder and liquid samples of the complaint batch in question were obtained, conditioned to 23°c, and mixed in the laboratory in a beaker under ventilated, temperature and humidity-controlled conditions (see ¿(b)(4) retest results.Pdf¿).(b)(4).No product problem or unusual observations were observed on the testing of the retained samples of this batch.(b)(4) was reviewed (see (b)(4) extract from (b)(4)-fde.Pdf).The patient codes reported in this complaint are included; in each case the risk is considered as low as possible and cannot be further mitigated.(b)(4) rev 2 was reviewed (see (b)(4) extract from (b)(4).Pdf).The patient codes reported in this complaint are included in the warnings section of the ifu.No information received with this individual complaint indicated that corrective action was necessary the number of complaints received for this failure mode will continue to be monitored and product updates/ recommendations will be implemented at the post market surveillance review dependent upon occurrence ratings.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as required.Device history lot : device history reviewed: (b)(4) unrelated non-conformances on this lot number.Final micro and sterility tests passed.Qc release specifications met.(b)(4) units released.Lot expiry date: 30 june 2022.

• Brand Name: SMARTSETGMV ENDURANCE GENT 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 11345991
• MDR Text Key: 232505237
• Report Number: 1818910-2021-03319
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3105040
• Device Lot Number: 9207065C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86 YR