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

Model Number	3332-040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Hemorrhage/Blood Loss/Bleeding (1888); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for stiffness and hemarthrosis.Event is not serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2015.Date of event: (b)(6) 2022.(right knee).Treatment: aspiration of 10ml of bloody fluid, sent for synovasure.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
On (b)(6) 2015, the patient had a right cemented total arthroplasty to address osteoarthritis, end-stage, secondary to previous acl reconstruction.Depuy components, including depuy patella were utilized during this procedure.On (b)(6) 2022 medical records note the patient had a previous fall, in which he hyperflexed his knee.The patient has been experiencing stiffness, pain, and limited range of motion.On 11/23/2022 phone record notes the patient has struggled with increasing pain and stiffness.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary; no device associated with this report was received for examination.Through follow up it is now understood there is no allegation associated against a product malfunction.Nothing indicative of a device nonconformance was found.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot; the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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 46581-0988 ; 3035526892
• MDR Report Key: 16014645
• Report Number: 1818910-2022-25818
• Device Sequence Number: 6371454
• Product Code: LOD
• UDI-Device Identifier: 30603295168632
• UDI-Public: 10603295168638
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2022

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 Model Number: 3332-040
• Device Catalogue Number: 3332040
• Device Lot Number: 8134388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 01/26/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 12/30/2022; 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• 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: DEPUY CMW 3 40G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA C/R NPOR FEM RT SZ 4; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX CRV INS SZ4 10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White