MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 11MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74027233
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed due to baseplate had subsided and bone had formed around it.It was removed via flexible ostetome and punch.Femur was removed via gigli saw and flexible ostetome.Tibia, teamed to 15 x 120, 4mm offset used, size 3 baseplate.All via standard technique.Trialled.Femur, reamed to 15 x 160, size 3.All via standard technique.Trialled implants were cemented in, 18mm constrained trial and knee balanced and then inserted.Wound closed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of complaint history did not reveal additional complaints for the listed batches.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, our investigation cannot proceed.If the devices or new information is received in the future, these complaints can be re-opened.The clinical medical investigation concluded there was no definitive root cause of the stated complaint or documentation to substantiate the reported subsidence.The provided x-ray images confirm some subsidence of the tibial baseplate.The revision was done due to complaint of pain was all that was stated, which the physician stated was caused by the subsidence.No further clinical documentation was provided.Additional patient impact or status is unknown.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 11MM
• 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: 8334200
• Report Number: 1020279-2019-00558
• Device Sequence Number: 16549340
• Product Code: JWH
• UDI-Device Identifier: 00885556179116
• UDI-Public: 00885556179116
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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 Catalogue Number: 74027233
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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