MAUDE Adverse Event Report: DEPUY CMW - 9610921 DEPUY CMW 1 40G; BONE CEMENT : BONE CEMENT

Catalog Number	3312040
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to loosening of the femur/tibia.The loosening interface was bone/cement.Doi: (b)(6) 2021.Dor: (b)(6) 2024.Affected side: right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.According to the information received, ¿patient was revised due to loosening of the femur/tibia.The loosening interface was bone/cement and the cement manufacturer was depuy synthes.Surgical delay was unknown." product description:- depuy cmw 1 40g, product code:- 3312040, lot no:- 9571712, quantity of manufactured:- (b)(4), date of manufacturing:- 06-aug-2020, expiry date:- 31-jul-2023.Product checked: retained samples.Required testing: tm-t150 cement setting time there are no non-conformances associated with this lot.The samples returned were tested in a temperature and humidity-controlled laboratory.Lot: 9571712, dough time: 01 min 30s (spec: 02 min 00s max), mix characteristics: soft., setting time: 08 min 57s (spec: 07 min to 10 min 30s).The cement mixed and behaved as expected for the product type and met the appropriate control specification (ref: ms-001 master specification: depuy cmw 1).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 : product description:- depuy cmw 1 40g, product code:- 3312040, lot no:- 9571712, quantity of manufactured:- (b)(4), date of manufacturing:- 06-aug-2020, expiry date:- 31-jul-2023.Device history review : a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: DEPUY CMW 1 40G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20707266
• Report Number: 1818910-2024-23962
• Device Sequence Number: 9604193
• Product Code: LOD
• UDI-Device Identifier: 10603295168614
• UDI-Public: (01)10603295168614(17)230731(10)9571712
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K053003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 3312040
• Device Lot Number: 9571712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 107 KG