MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 3; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number 74022113

Device Problem Misassembled (1398)

Patient Problem Injury (2348)

Event Date 01/22/2019

Event Type  Injury  

Event 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.

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 BCS II FEMORAL OXIN RT SZ 3
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8334152
• MDR Text Key: 135985410
• Report Number: 1020279-2019-00553
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556169810
• UDI-Public: 00885556169810
• Combination Product (y/n): N
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2024
• Device Catalogue Number: 74022113
• Device Lot Number: 14HM01808
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention