MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ 3 LEFT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420164
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported tha the tibia and poly were removed during a revision surgery.The tibia was loose upon opening the joint capsule.It was removed with no cement adhered to the baseplate.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.However, the lack of cement reported in the complaint could not be ruled out as a contributing factor to the reported revision.The patient impact beyond the reported revision could not be determined.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ 3 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: 8700950
• Report Number: 1020279-2019-02266
• Device Sequence Number: 1942159
• Product Code: JWH
• UDI-Device Identifier: 03596010206251
• UDI-Public: 03596010206251
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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: 03/03/2026
• Device Catalogue Number: 71420164
• Device Lot Number: 16CT66030
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 72453278.; PART NUMBER 71453278/LOT NUMBER 15MM18925.; 72453278
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention