MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 3-4 LT13; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY

Catalog Number	74023244
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	09/08/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was diagnosed with mid-flexion instability, left knee, status post total knee arthroplasty.A revision surgery was performed to exchange polyethylene component.A size 3, 18mm journey tibial component was implanted.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.A review of the complaint history revealed no prior complaints for the listed lot.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our clinical/medical team concluded: : the root cause of the mid-flexion instability cannot be concluded; however, currently unable to rule out the patient¿s reported peripheral neuropathy/potentially weakened supporting soft tissues and/or possible deficient collateral ligaments as possible contributing factors to the reported event as the primary implants reportedly provided ¿excellent stability¿ and ¿appropriate laxity at 30 degrees flexion to varus and valgus stress¿ post-primary(b)(6) and was reportedly corrected during the revision with a thicker articular insert, which also did not reflect component mal-performance.The patient impact beyond the reported early post-primary mua, the mid-flexion instability, and the revision/thicker insert/exchange with an expected brief post-operative rehabilitation phase cannot be concluded.No further medical assessment can be rendered at this time.Without the actual product involved 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.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical task, based on the documentation provided, the root cause of the reported early onset of reduced rom was likely the well-known complication of arthrofibrosis which was released during the mua thus providing full rom post-procedure[(b)(4)] and did not suggests component failure.The root cause of the mid-flexion instability cannot be concluded; however, currently unable to rule out the patient¿s reported peripheral neuropathy/potentially weakened supporting soft tissues and/or possible deficient collateral ligaments as possible contributing factors to the reported event as the primary implants reportedly provided ¿excellent stability¿ and ¿appropriate laxity at 30 degrees flexion to varus and valgus stress¿ post-primary[c-216908] and was reportedly corrected during the revision with a thicker articular insert, which also did not reflect component mal-performance.The patient impact beyond the reported early post-primary mua, mid-flexion instability, and revision/thicker insert exchange with an expected brief post-op rehab cannot be concluded.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch/failure mode.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: JOURN ART INS BCS STD 3-4 LT13
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8167865
• Report Number: 1020279-2018-02801
• Device Sequence Number: 16194033
• Product Code: JWH
• UDI-Device Identifier: 03596010555090
• UDI-Public: 03596010555090
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2019

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: 05/11/2017
• Device Catalogue Number: 74023244
• Device Lot Number: 07EM11779
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018; 11/16/2018
• Initial Report FDA Received Date: 12/16/2018
• Supplement Report FDA Received Date: 05/15/2019; 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71932911/08KM05419.; 74021123/09AM05832.; 74022223/10DM03447.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR