MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 5-6 9MM; PRSTHESIS,KN,PTLLFMRTIBIAL,SMI-CNSTRND,CMNTD,POLYMR/MTAL/POLYMER

Catalog Number	74025651
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after implanting the femur and tibia, surgeon put in the poly.Once in place, he could not get the poly to advance posteriorly and lock in to place.Multiple attempts and same result with subsequent polys.There was a consistent deformation on the posterior medial portion of the used polys.Multiple check were made to ensure the posterior aspect of the tibia tray was clear of any tissue or possible cement.Finally was able to get the 4 poly to engage after trimming some of the deformed plastic with a surgical instrument.The surgical time was extended for approximately 1 hour.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A visual inspection of the returned inserts indicated damage to the locking details and dovetails.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.The features that could be measured were within specification.A clinical analysis indicated that several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.No harm to the patient was reported except for the additional surgery time.Should information become available this complaint can be re-assessed.A review of complaint history on the listed parts revealed no additional complaints for the listed batches.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JRNY II CR ISRT XLPE RT SZ 5-6 9MM
• Common Device Name: PRSTHESIS,KN,PTLLFMRTIBIAL,SMI-CNSTRND,CMNTD,POLYMR/MTAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7653699
• Report Number: 1020279-2018-01244
• Device Sequence Number: 18876040
• Product Code: JWH
• UDI-Device Identifier: 00885556422465
• UDI-Public: 00885556422465
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

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 Catalogue Number: 74025651
• Device Lot Number: 17LM20505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/30/2018
• Supplement Report FDA Received Date: 09/14/2018
• 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