MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3095040

Device Problem Chemical Problem (2893)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The cement did not set well.The surgeon had to recover the patient again.

Manufacturer Narrative

Product complaint #
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>(b)(4) investigation summary
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> the complaint states "the cement did not set well.The surgeon had to recover the patient again" the retained samples were tested in a temperature and humidity-controlled laboratory (see attachment ¿(b)(4)retest results.Pdf¿).Mean dough time: 0 min 49 sec mean setting time: 10 min 54 sec mix characteristics: firm handling characteristics: firm the reported failure was not repeated in the testing of the retained samples for this lot number.The cement mixed and behaved as expected for the product type and met appropriate specifications.The complaint description cannot be confirmed from the results of this testing.Root cause cannot be determined from the results of this testing.Dva-107020-fde rev 9 was reviewed, and this failure mode is included on lines 61, 62, 72, 73, 74, 75, and 177.In each case, the risk is considered ¿as low as possible¿ and cannot be further mitigated.See attachment(b)(4) extract from dva-107020-fde.Pdf¿.The mixing and use of bone cement can be significantly affected by exposure to high or low temperatures up to 24 hours before use.The optimum temperature for bone cement is 23 degrees celsius as per the ifu.Conclusion and further action: a root cause cannot be determined as the complaint problem has not been possible to replicate with the testing of the retained samples.However, the conditioning and storage of the product, or the operating theatre temperature could have potentially aided the unusual behaviour mentioned.No information received with this individual complaint indicated that a broader investigation or 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
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> device history reviewed 29 september 2020 2 unrelated non-conformances on this lot number.Final micro and sterility tests passed product met all quality control acceptance criteria.(b)(4) units released.Lot expiry date: 31 january 2021.

• Brand Name: SMARTSET GHV GENTAMICIN 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: 10363498
• MDR Text Key: 201595265
• Report Number: 1818910-2020-17514
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K033563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3095040
• Device Lot Number: 9465399
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1