MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE PS INSERT SZ 5-6 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453254
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Disorder (2373)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed.Patient needed to get the right tk done and so at the same time he has requested that we increase the thickness of his insert so we can improve the stability of his left knee.Exchanged the insert for a 15 mm constrained stabilized insert for left knee.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, based on the operative notes, the existing and persistent ¿lax collateral ligament¿ of the left knee most likely resulted in a (loose/asymmetrical) gap imbalance which subsequently led to the early post-op flexion and mid-flexion instability which was partially corrected within a ¿1mm jog of lateral instability¿ with the 15mm revision articular insert.Additionally, the early onset of symptoms and known laxity along with the delay in revision potentially contributed to the severity of the patient¿s worsening symptoms.The patient impact was the continued pain, inability to sleep and other reported progressive symptoms in addition to the revision surgery with an expected brief post-operative rehabilitative phase.However, due to the persistent (albeit minor) lateral laxity/instability post-revision, future similar concerns cannot be definitively excluded.No further medical assessment can be rendered at this time.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.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.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, based on the operative notes, the existing and persistent ¿lax collateral ligament¿ of the left knee most likely resulted in a (loose/asymmetrical) gap imbalance which subsequently led to the early post-op flexion and mid-flexion instability which was partially corrected within a ¿1mm jog of lateral instability¿ with the 15mm revision articular insert.Additionally, the early onset of symptoms and known laxity along with the delay in revision potentially contributed to the severity of the patient¿s worsening symptoms.The patient impact was the continued pain, inability to sleep and other reported progressive symptoms in addition to the revision surgery with an expected brief post-operative rehabilitative phase.However, due to the persistent (albeit minor) lateral laxity/instability post-revision, future similar concerns cannot be definitively excluded.No further medical assessment can be rendered at this time.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.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.

• Brand Name: LGN XLPE PS INSERT SZ 5-6 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7921370
• Report Number: 1020279-2018-02022
• Device Sequence Number: 1585615
• Product Code: JWH
• UDI-Device Identifier: 00885556255834
• UDI-Public: 00885556255834
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2019

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: 08/08/2026
• Device Catalogue Number: 71453254
• Device Lot Number: 16HM06806
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018; 09/05/2018
• Initial Report FDA Received Date: 09/30/2018
• Supplement Report FDA Received Date: 03/27/2019; 04/08/2019
• 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: 52 YR