MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CEM TIB SIZE 8 RIGHT; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71420191
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/05/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was diagnosed with loosening of right total knee arthroplasty after tka in 2012 and post resurfacing of the patella plus increase in the thickness of the poly insert to 13mm in 2014.A revision surgery was performed and the tibial baseplate, femoral component and the poly insert were replaced.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and based on the available information, the root cause for ¿pain and stiffness¿ that resulted in the resurfacing and larger size insert cannot be concluded.However, it is not an uncommon occurrence if the patella was not resurfaced during the primary surgery.Nor can the root cause of the ¿aseptic loosening¿ that resulted in the revision of the tibial base plate and polyethylene liner with an ¿irrigation and debridement¿ be concluded as aseptic loosening can have several causes.No current information on this patient¿s current status has been provided 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.We consider this investigation closed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.Our clinical team has concluded that based on the available information, the root cause for ¿uncontrolled pain and possible acute infection¿ or the later ¿pain and stiffness¿ that resulted in the resurfacing and larger size insert cannot be concluded.However, it is not an uncommon occurrence if the patella was not resurfaced during the primary surgery.Nor can the root cause of the ¿aseptic loosening¿ that resulted in the revision of the tibial base plate and polyethylene liner with an ¿irrigation and debridement¿ be concluded as aseptic loosening can have several causes.At a (b)(6) 2017 ¿ follow-up comparison of x-rays to (b)(6) 2016 ¿ ¿no visible periprosthetic fracture of significant lucency¿.This patient has now had left hip total hip arthroplasty.A review of the manufacturing records for the provided batches did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved our investigation cannot proceed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.

• Brand Name: GNS II CEM TIB SIZE 8 RIGHT
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7924876
• Report Number: 1020279-2018-02012
• Device Sequence Number: 11153043
• Product Code: JWH
• UDI-Device Identifier: 03596010206381
• UDI-Public: 03596010206381
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2019

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: 03/28/2021
• Device Catalogue Number: 71420191
• Device Lot Number: 11CM20500
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018; 11/11/2019
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 12/04/2018; 11/15/2019
• 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: 61 YR