MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 DEPUY CMW 2G 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3325040

Device Problem Chemical Problem (2893)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4).This event is now being submitted under this mrn number and will no longer be submitted under mrn 1818910-2024-00252.Any further follow-ups will continue to be submitted under this current mrn.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 Description

The surgeon described the bone cement to be very runny in consistency over the past few months, as well as the cement¿s setting time to differ from the usual.The events occurred during surgery, and did not cause any surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).G4: no 510k as device is not marketed in the united states under this product code, but the same/similar product is marketed in the us under a different product code.D2b: procode inadvertently submitted as "mbb", the correct procode should be "lod".

Manufacturer Narrative

Product complaint #
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> (b)(4) investigation summary
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> no device associated with this report was received for examination.Lot: 4200156 manufacturing date: (b)(6) 2023 expiry date: 31 may 26 quantity: (b)(4) product checked: retained samples.Required testing: tm-t150 cement setting time there is one non-conformance associated with this batch.The non-conformance would have no impact to the cement performance.The samples returned were tested in a temperature and humidity-controlled laboratory.Lot: 4200156 dough time: 59 s (spec: 1 min 30s) mix characteristics: firm setting time: 5 min 25s (spec: 4 min 00s to 6 min 00s) the cement mixed and behaved as expected for the product type and met the appropriate control specification.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
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> a manufacturing record evaluation was performed for the finished device product code: 3325040 and lot number: 4200156 has no non-conformances/ manufacturing irregularities related to the malfunction were identified.H10 additional narrative: added: d4 (expiration date), d10 and h4.

• Brand Name: DEPUY CMW 2G 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool ; UK
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18539705
• MDR Text Key: 333199742
• Report Number: 1818910-2024-01342
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081163
• 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: 01/18/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3325040
• Device Lot Number: 4200156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DEPUY CMW 2G 40G