MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ 2 LEFT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420162
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that left knee revision surgery was performed due to loosening of the tibia component.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, based on the documentation provided, the root cause of the tibial component loosening, ¿subsidence¿ and subsequent revision was most likely ¿(having failed her earlier cement fixation) ¿because of the bone infarcts¿ (c-241697, c-241698); however, interval radiological imaging was not provided for evaluation.¿significant bone loss from removal of the femoral component¿ occurred due to the implant being stable but was deemed necessary for tibial ¿access¿ and to match rotation, position, and alignment of the extremity¿ (c-241699).The patient impact beyond the tibial loosening, revision and subsequent femoral bone loss cannot be determined.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ 2 LEFT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8547007
• Report Number: 1020279-2019-01651
• Device Sequence Number: 1744641
• Product Code: JWH
• UDI-Device Identifier: 03596010206244
• UDI-Public: 03596010206244
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 10/21/2019

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: 10/17/2024
• Device Catalogue Number: 71420162
• Device Lot Number: 14KM13247
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 55 YR