MAUDE Adverse Event Report: DEPUY CMW - 9610921 DEPUY CMW 3 40G; BONE CEMENT : BONE CEMENT

Catalog Number	3332040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fall (1848); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Study no: (b)(6).Clinical adverse event received for adhesions: is this event related to the study device? not related.Is this event related to the study procedure? remote possibility.Date of event: 28/aug/2024.Additional event information: clinic note added: (b)(6) 2024.On (b)(6) 2024, medical records note, the patient is four years post right total knee arthroplasty.The patient was noted, to have arthrofibrosis knee with pain and stiffness.The patient had a scar tissue surgery with open resection, poly swap in the past.The patient then fell and had regression and return of arthrofibrosis.The patient has increased pain, difficult time with mobility.An aspiration of knee was performed.And negative for any time of bacterial infection.The surgeon suggested, total knee arthroplasty revision for arthrofibrosis.
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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The adverse symptoms alleged and product code reported is associated with the depuy metal on metal articulation.A complaint database search and/or device manufacturing (dhr) reviews will not be performed.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 : device history reviewed: no non-conformances on this batch.Final micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found 1 additional report, however no other incidents related to gastrointestinal bleeding.Total for lot number: 0 (b)(4) complaints received by cmw in the last 12 months for this issue ¿ by product code: 0.By product family: 0.

• Brand Name: DEPUY CMW 3 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 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20223280
• Report Number: 1818910-2024-19339
• Device Sequence Number: 20797831
• Product Code: LOD
• UDI-Device Identifier: 10603295168638
• UDI-Public: (01)10603295168638(17)201231(10)8716090
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 3332040
• Device Lot Number: 8716090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MBT CEM KEEL TIB TRAY SZ2; PFC*SIGMA C/R NPOR FEM RT SZ 2; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX CRV INS SZ2 10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 59 KG