MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 3-4 LT11; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74023243
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/04/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to exchange liner due to anterior-posterior instability.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and this complaint reports that a revision surgery was performed to exchange liner eleven months post implantation due to anterior-posterior instability.No gross instability was noted on preoperative evaluation.During the revision the previous incision used.The patella was gently retracted laterally as the knee was flexed to 110 degrees.Inspection of the prosthesis demonstrated no evidence of loosening, disassembly, or malalignment.There was no laxity to varus-valgus stress from 0 to 30 degrees.There was mild recurvatum, which was consistent with a preoperative state.The polyethylene insert was then removed.A smith and nephew journey bi-cruciate stabilized revision articular insert was seated on the baseplate.A review of complaint history on the listed part revealed no prior complaints for the listed batch 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.

• Brand Name: JOURN ART INS BCS STD 3-4 LT11
• 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: 8359362
• Report Number: 1020279-2019-00729
• Device Sequence Number: 1682889
• Product Code: JWH
• UDI-Device Identifier: 03596010555083
• UDI-Public: 03596010555083
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2019

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: 12/15/2018
• Device Catalogue Number: 74023243
• Device Lot Number: 08MM14675
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 06/19/2019
• 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: 67 YR