MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. UNIVERSAL FEM SLV DIS POR 40MM; KNEE OTHER IMPLANT

Catalog Number	129453235
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	04/10/2017
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
Clinical der states that the patient was revised to address suspected infection.The event has a remote possibility of being device related and is definitely not procedure related.Update 6-21-2017: medical records have been reviewed.Office notes (b)(6) 2017 indicate the patient has been experiencing significant pain.Radiology reports indicate tibial subsidence with lucency around the entire tibial component.There is also lucency between the cement and bone interface on the femoral component, but no indication of gross femoral failure.Clinical impression: failed right total knee arthroplasty, suspected infection.Revision notes (b)(6) 2017: the patient right knee has been bothersome for many years with evidence of loosening of the tibial components.Due to his history of left knee infection it was thought there could be an occult chronic infection in the right knee causing loosening vs aseptic loosening.Due to this and the patient's significant symptoms with chronic effusion and chronic pain, loosening of the components radiographically, it was felt exploration with revision was needed.At revision, the surgeon noted there was clear fluid within the joint.There was metallosis noted immediately.Synovectomy was performed.The femoral component was freely rotating on distal femur.The tibial component was also loose, all were disimpacted and removed.There was mildly significant bone loss in the tibia.It should be noted that there were no slimy tissue or significant thickening of the capsular tissue that would one would expect with a chronic inflammatory response to infection.Attention was turned to the femur.While working with the femur it is noted that a small piece of bone broke off from the femur and this was cerclaged in place.There was also another very small perforation of the proximal femur.It was decided at this time to use a tibial nail along with stimulan cement.The wound was then closed.It should be noted that all cultures taken at time of explantation were negative.Office notes (b)(6) 2017: patient is progressing well and is ready for re-implantation.Re-implantation with biomet products occurred on (b)(6) 2017.Updated on 7-18-2017.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.This does not meet a complaint definition, the electronic complaint record will be voided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNIVERSAL FEM SLV DIS POR 40MM
• Common Device Name: KNEE OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6721390
• Report Number: 1818910-2017-21281
• Device Sequence Number: 13508040
• Product Code: NJL
• UDI-Device Identifier: 10603295026327
• UDI-Public: 10603295026327
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 129453235
• Device Lot Number: 414791
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 08/01/2017
• 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: 65 YR
• Patient Weight: 95