MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DEPUY CMW 2 20G; BONE CEMENT : BONE CEMENT

Catalog Number	3322020
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2015, the patient had an right total knee arthroplasty.Depuy components including depuy cement and implants were utilized during this procedure.On (b)(6) 2024, the patient had a revision of right total knee to address pain, swelling, discomfort, instability and difficulty ambulating.Limited range of motion was also alleged.Operative findings were noted that the tibial tray was grossly loose at tibial tray/cement.Doi: (b)(6) 2015.Dor: (b)(6) 2024.Affected side: right knee.
Additional Manufacturer Narrative
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.Additional narrative: e1: reporter is a legal professional.D6, h4: the information provided regarding the manufacturing date and implantation date are identified to be conflicting.Continued follow-up is being conducted and any additional information received will be reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Product description- depuy cmw 2 20g.Product code- 3322020.Lot no- 8280491.Quantity of manufactured- (b)(4).Date of manufacturing- 2016-03-30.Expiry date- 2019-02-28.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 2 20g.Product code- 3322020.Lot no- 8280491.Quantity of manufactured- (b)(4).Date of manufacturing- 2016-03-30.Expiry date- 2019-02-28.Device history review = > a manufacturing record evaluation was performed for the finished device [lot/serial/batch] number, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: DEPUY CMW 2 20G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21762187
• Report Number: 1818910-2025-04953
• Device Sequence Number: 15576012
• Product Code: LOD
• UDI-Device Identifier: 10603295168621
• UDI-Public: (01)10603295168621(17)20190228(10)8280491
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• 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: 02/28/2019
• Device Catalogue Number: 3322020
• Device Lot Number: 8280491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2016
• 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 Sex: Female