MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 35MM; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Model Number	71421035
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 21 months ago the patient underwent a total knee replacement for her left knee and she is still in incredible pain, it often feels very warm and very tight.There is a large indentation on the bottom left of her knee, and a "knife stabbing" and "out of place" sensation.The doctor said it was the implant opening up when bent.The pain is often below the kneecap.The patient is using a patella brace, kinesio tape, physical therapy and putting ice on the knee.
Additional Manufacturer Narrative
It was reported that after a total knee replacement for her left knee approximately 2 years ago, the patient is still in incredible pain, as it often feels very warm and very tight.The affected genesis ii oval resurfacing patellar component, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A clinical analysis noted that the post-tka radiological images show ¿mild left lateral patellar tilt¿ which is persistent in the interim images since implantation along with mineralized bodies within the posterior aspect of the left knee joint; however, reports indicated the components were anatomically aligned.Per the mri report, no itb (iliotibial band) disruption was noted, nor direct nerve impingement; although ¿mild scarring of the subcutaneous fascia overlying the patellar tendon insertion onto the tibial tuberosity¿ was noted along with mild scar remodeling of the cruciate ligament.The provided operative report did not provide insight into the reported events.A lateralization of the patella is noted, its contribution could neither be concluded nor ruled out.The reported posterior osseous bodies, lateral patellar tilt, and/or overstuffing of the patellofemoral joint also could not be ruled out as possible contributing factors to the reported progressive symptoms.The patient impact beyond the reported signs/symptoms could not be determined and no further intervention has been reported.No further medical assessment can be rendered at this time.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: GII OVAL RESURFACING PAT 35MM
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10199452
• Report Number: 1020279-2020-02766
• Device Sequence Number: 948814
• Product Code: JWH
• UDI-Device Identifier: 03596010485076
• UDI-Public: 03596010485076
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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 Model Number: 71421035
• Device Catalogue Number: 71421035
• Device Lot Number: 18CM04426
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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