MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FEM OX NP BCS LT SZ 3; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY

Catalog Number	74021123
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Fibrosis (3167)
Date of Event	09/23/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a manipulation under anesthesia was performed due to patient was diagnosed with arthrofibrosis left knee, status post total knee arthroplasty.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and 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[c-224862-c-224865] 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, 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.A review of complaint history on the listed parts revealed no prior complaints for the listed batches 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.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and 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)(6)] 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 [(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, mid-flexion instability, and revision/thicker insert exchange with an expected brief post-op rehab cannot be concluded.A review of complaint history on the listed parts revealed no prior complaints for the listed batches 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.

• Brand Name: JOURNEY FEM OX NP BCS LT SZ 3
• 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: 8167881
• Report Number: 1020279-2018-02805
• Device Sequence Number: 18880746
• Product Code: JWH
• UDI-Device Identifier: 03596010554147
• UDI-Public: 03596010554147
• 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
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2019

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: 01/07/2019
• Device Catalogue Number: 74021123
• Device Lot Number: 09AM05832
• 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: 03/21/2019; 11/04/2019
• 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; Other
• Patient Age: 53 YR