MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74021153
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a revision surgery performed due to loosening of tibial baseplate and femoral component.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A review of complaint history revealed no prior complaints for the listed lots.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Our clinical/medical team noted that based on the radiologic report five months prior to revision there was a lytic or lucent reaction around the prosthesis on the femoral and the tibial side and valgus, the bone scan report of probable tibia loosening.In addition to, intra-operative findings of the ease of removal of both the femur and the tibia components confirms the loosening of the tibial and femoral components.However, without the culture report, radiographs, or the explants the root cause of the tibia component loosening cannot be determined.In addition, we cannot rule out the patient¿s age, activity level, history of bone-on-bone osteoarthritis, subchondral sclerosis, osteophytes, elective prophylactic mastectomy (if cancer was involved), as contributing factors.The future impact to the patient beyond the revision surgery cannot be determined.No further clinical/medical assessment is warranted at this time.

• Brand Name: JRNY II CR FEM OX NP RT SZ 3
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7945376
• Report Number: 1020279-2018-02118
• Device Sequence Number: 19067929
• Product Code: JWH
• UDI-Device Identifier: 00885556422861
• UDI-Public: 00885556422861
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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 Expiration Date: 07/04/2025
• Device Catalogue Number: 74021153
• Device Lot Number: 15GM03417
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 01/02/2019
• 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: Other; Required Intervention
• Patient Age: 77 YR