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

Model Number	71453223
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Joint Laxity (4526)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in a poly swap case on (b)(6) 2020.The swap on the instrument happened due to the knee was unstable and the doctor wanted to add thickness to the poly to stabilize the joint.When the incision was made and got to the joint, it was noticed that the post from the poly insert that was implanted on (b)(6) 2019 had broken.No delay reported.The procedure was completed using the new poly.
Event or Problem Description
It was reported that, 7 months after a primary right tkr was performed, the patient started suffering from suffering from pain, swelling, popping, and locking of the knee.Due to this, the patient was scheduled for an arthroscopic evaluation of the knee.During the evaluation, the surgeon decided to change the procedure to an open revision.The swap on the instrument happened due to the knee was unstable and the doctor wanted to add thickness to the poly to stabilize the joint.When the incision was made and got to the joint, it was noticed that the post from the poly insert that was implanted on 6-feb-2019 had broken.No delay reported.The procedure was completed using the new poly.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.The lab analysis concluded that the as received component was visually inspected for signs of damage.The tibial insert showed signs of wear related damage to the articulating surface.There were signs of deformation on the anterior and posterior edges of the articular surface indicating potential excessive rotation of the femoral component relative to the insert.The post was fractured near the base of the post region and beach marks were observed on the fracture surface.Signs of deformation were observed on the anterior, posterior, medial, and lateral regions of the insert post.No material or manufacturing defects were observed during this investigation.The clinical/medical evaluation concluded that per the lab retrieval analysis, there were no material or manufacturing defects observed, and the noted deformation indicated ¿potential excessive rotation of the femoral component relative to the insert.Based on this information, excessive rotation of the knee/patient activity, could therefore, not be ruled out as a potential contributing factor to the reported post breakage and device failure cannot be confirmed as root cause.It is unknown if the 10 months-time elapsed between the onset of symptoms and the revision procedure could have also contributed to the event, as reportedly there was no clinical findings/knee laxity noted during follow-up visits.The reported patient impact was the ongoing symptoms, fractured insert post, imaging, and open right tka revision/poly-exchange.Further patient impact could not be assessed based on the limited information provided.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 5-6 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10423451
• Report Number: 1020279-2020-04030
• Device Sequence Number: 2960998
• Product Code: JWH
• UDI-Device Identifier: 00885556033425
• UDI-Public: 00885556033425
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71453223
• Device Catalogue Number: 71453223
• Device Lot Number: 18KM18948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2021
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 07/19/2021; 09/28/2021
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 07/27/2021; 09/28/2021
• 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: UNKNOWN GENESIS II TOTAL KNEE FEMORAL COMPONENT; UNKNOWN GENESIS II TOTAL KNEE TIBIAL BASEPLATE
• Patient Age: 73 YR