MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR PS NP FEMORAL COMP SZ 4 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420102
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision knee arthroplasty was performed due to a loose femoral component.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported subsided stem cannot be determined.However, based on the physician¿s report the likely cause of the subsiding stem was due to the undersized implantation stem prosthesis.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.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 product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GEN II COCR PS NP FEMORAL COMP SZ 4 LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7986782
• Report Number: 1020279-2018-02227
• Device Sequence Number: 1552298
• Product Code: JWH
• UDI-Device Identifier: 03596010205957
• UDI-Public: 03596010205957
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: 04/14/2022
• Device Catalogue Number: 71420102
• Device Lot Number: 12DM08433
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 04/09/2019
• 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