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); Swelling/ Edema (4577)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for continued pain and migration/loosening of tibia.Event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2016.Date of event: (b)(6) 2022.(right knee).Treatment: revision; tibial and insert were revised.
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: 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
Medical records received indicate that the patient presents for a clinical follow-up of his right knee, which had been revised six years prior.He presents with pain and mild effusion, and x-rays show gross tibial loosening.The femur appears to be well-fixed, with only marginal lucency along the distal portion.(b)(6) 2023: patient returned for further clinical follow-up of the right knee.In addition to what was observed in the prior follow-up, the tibial cement mantle is broken.The plan is to revise, but the patient is seeking a second opinion to confirm the plan.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence found a gap between the cement and the bone.However, the reported loosening allegation could not be confirmed without a series of x-rays to review.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 IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16089178
• Report Number: 1818910-2023-00228
• Device Sequence Number: 2045525
• Product Code: LOD
• UDI-Device Identifier: 10603295168638
• 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: 2016
• 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): 01/03/2023

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 Model Number: 3332-040
• Device Catalogue Number: 3332040
• Device Lot Number: 8367469
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 01/04/2023; 02/09/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/20/2023; 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BIOMET FEMORAL COMPONENT.; BIOMET PATELLA.; BIOMET TBIAL TRAY.; BIOMET TIBIAL INSERT.; DEPUY CMW 2 20G.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 155 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White