MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTMIX CEMVAC + GHV 80G; BONE CEMENT : BONE CEMENT

Catalog Number 8195080

Device Problem Chemical Problem (2893)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  malfunction  

Event Description

It was reported that during cementing surgeon noted that initially the cement was too viscous and then it became solid.As a result he bailed out and removed the cement from the femur in order to start again.Prior to recementing he inserted a narrow catheter into the canal to drain fluids and upon removal noted that the tip of the catheter was not present and believed that it was still in the femoral canal.He cited that the initial cement residue may have snagged the catheter.

Manufacturer Narrative

Product complaint # (b)(4).Dmf# - (b)(4).Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.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.

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: added: b5 and h6 (impact code) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received: 1.Was/were there any adverse consequence/s that affected the patient because of the reported event? no.2.Was there a surgical delay? if yes, what is the duration of the delay? yes approx 10mins 3.How was the cement prepared for use? it was a prefilled device.4.What equipment was used to prepare/mix the cement? it was a prefilled device.5.What was the timing to mix and the time between mixing and setting? approx 60 seconds ¿ it wasn¿t set by the time the surgeon decided not to use it.6.What equipment was used to deliver the cement? it was a prefilled syringe with cemvac gun.7.What was the storage temperature of the cement before usage? 15 degrees approx 8.What was the or temperature during the use of the cement? 21 degrees approx 9.Was there any patient harm relevant to this event? if yes, please kindly provide the details.There was a small fragment of a catheter which was left in the femur.

Event Description

Usfda mdr determination: there is no indication that the time delay occurred at a critical procedural step where high risks to the patient may be present.There is no indication that the delay resulted in any impact to the expected surgical outcome.An additional cement unit was readily available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received, "the surgeon requested that i raise a complaint because during cementing he noted that initially the cement was too viscous and then it became rapidly solid.As a result he bailed out and removed the cement from the femur in order to start again.Prior to recementing he inserted a narrow catheter into the canal to drain fluids and upon removal noted that the tip of the catheter was not present and believed that it was still in the femoral canal.He cited that the initial cement residue may have snagged the catheter.¿ the product was not returned to depuy synthes, however a photo was provided for review.(b)(4).The photograph attached was reviewed, however the photo only shows the information of the product that its attached on the carboard packaging.No other observation pertaining to the nature of the reported event could be identified.A retain sample was performed and revealed that the cement mixed and behaved as expected for the product type and met the appropriate control specification.A manufacturing record evaluation was performed for the finished device [8195080 / 4251032] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The overall complaint was not confirmed as the observed condition of the smartmix cemvac + ghv 80g 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 : a manufacturing record evaluation was performed for the finished device [8195080 / 4251032] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.

• Brand Name: SMARTMIX CEMVAC + GHV 80G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18776744
• MDR Text Key: 336543458
• Report Number: 1818910-2024-04263
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: OUS - SIMILA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8195080
• Device Lot Number: 4251032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1