MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DEPUY CMW 3 40G; BONE CEMENT : BONE CEMENT

Model Number	3332-040
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint Laxity (4526)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the patient had a revision left tka both components and patella, to address failed tka with aseptic loosening and fracture of the previous revision tibial stem.During the procedure the surgeon observed an abundance of intra-articular fibrosis/fibrotic tissue, the tibial tray was grossly loose (uncemented), a large defect of the medial tibial plateau, and fracture of the stem at the junction between the stem and the tibial baseplate.Competitor components, including patella were implanted during this procedure, along with depuy cement.On (b)(6) 2022 medical records note the patient has loosening and subsidence and instability/ligamentous laxity in the tka along with pain.On (b)(6) 2022 the patient had a revision left tka tibial component, prophylactic plating of left tibia to address recurrent left tka failure with recurrent varus tibial collapse.Competitor components were implanted during this procedure.The patient¿s history included multiple-revisions of the left knee.The patient has had recurrent breakage of his tibial baseplate from the uncemented tibial stem.During the surgery, the surgeon remarked that there were no signs of infection.There was synovitis consistent with metal debris, which is consistent with the broken tibial construct.The patient had a grade 3a uncontained (bone) defect of the medial tibial plateau.The patellar and femoral component were noted to be stable.Depuy cement x3 was used during this procedure.
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.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).Investigation summary : no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.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 ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 15994668
• Report Number: 1818910-2022-25602
• Device Sequence Number: 17629784
• Product Code: LOD
• UDI-Device Identifier: 30603295168632
• UDI-Public: 10603295168638
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K053003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 3332-040
• Device Catalogue Number: 3332040
• Device Lot Number: 9173968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2019
• 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; DEPUY CMW 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; FEMORAL 40 MM M/L 22 MM A/P SLEEVE; FEMORAL LOCKING BOLT; FEMORAL TAPERED JUNCTION BOX 5; PATELLA 38 MM; SIZE 5 MODULAR TIBIAL TRAY NEUTRAL; SIZE 6 FEMORAL AUGMENT DISTAL 4MM; STEM 17 MM 150 MM SLOTTED; STEM 19MM 110 MM SLOTTED; TIBIAL INSERT REVISION CK SZ 5 14 MM; TIBIAL LARGE CONE 58 MMM/L 35 MM A/P
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male