MAUDE Adverse Event Report: DEPUY RAYNHAM ¿ 1219655 SIG PS CEM FEM W/LUGS LT SZ4; KNEE FEMORAL COMPONENT

Catalog Number	196064500
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Joint Swelling (2356); Limited Mobility Of The Implanted Joint (2671)
Date of Event	09/21/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Medical records received (b)(6) 2017.Revision due to pain, grinding/popping sensation, persistent swelling and limited mobility with aseptic loosening of the tibial and femoral components - cement to implant interface.On (b)(6) 2017 medical records and claim letter reviewed.Primary operative notes (b)(6) 2012 indicate the patient received a left total knee arthroplasty due to degenerative joint disease of the left knee.Procedure was completed without complication noted.Post-op x-ray reveals a well seated left knee arthroplasty with no fractures or dislocations.Office notes (b)(6) 2015 indicate the patient presents with pain, grinding/popping sensation, swelling and limited mobility.Bone scan results show signs of implant loosening.Revision operative notes (b)(6) 2015 indicate the patient received a left total knee arthroplasty revision due to left knee pain, persistent swelling and limited mobility with aseptic loosening of the tibial and femoral components.Pathology findings from submitted intra-op specimen joint fluid revealed no signs of acute inflammation, gram stain shows rare wbc, no organisms seen.Procedure detail indicates that the patella was quite stable.The femoral component was felt to be loose and was removed with only a small amount of bone loss.The tibial component was grossly loose within the mantle and could be lifted without any difficulty.Procedure was completed without complication noted.Office notes (b)(6) 2016 indicate the patient is currently experiencing a little bit of swelling and not much discomfort.Left total knee has no ligamentous instability, well healed incision.Updated 10-5-2017.
Additional Manufacturer Narrative
No device associated with this report was received for examination.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIG PS CEM FEM W/LUGS LT SZ4
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY RAYNHAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6921994
• Report Number: 1818910-2017-26150
• Device Sequence Number: 827754
• Product Code: NJL
• UDI-Device Identifier: 10603295075301
• UDI-Public: 10603295075301
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2017

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 Catalogue Number: 196064500
• Device Lot Number: 218379
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 103