SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number 71420576 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arthralgia (2355); Ambulation Difficulties (2544); Unequal Limb Length (4534); Swelling/ Edema (4577)
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Event Date 07/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, after a total knee replacement on the left knee had been performed on (b)(6) 2021, the patient never stopped having pain and swelling; difficulty walking and sitting for a long time; problems going up and down stairs, kneeling and remaining stood up for periods of one hour.The pain is constant and difficulting daily activities.The patient also walks with a limp as the right leg is shorter than the left.Patient has continued physical therapy, but there has not been any change and the knee is not improving.Patient also had manipulation under anesthesia at some point after the knee replacement.The situation is ongoing.The patient is bilateral: the right prosthetic knee was implanted on 2022.
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that no supporting medical documentation has been provided as there was reportedly no contact information provided.Based on the limited information provided, definitive contributing clinical factors could not be concluded.The current patient status is unknown.The patient impact beyond that which was reported cannot be determined.No further medical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that a decreased range of motion, pain and shortening of the leg has been identified in possible adverse events.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Event Description
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It was reported that, after a total knee replacement on the left knee had been performed on (b)(6) 2021 with a legion system, the patient never stopped having pain and swelling; difficulty walking and sitting for a long time; problems going up and down stairs, kneeling and remaining stood up for periods of one hour.The pain is constant and difficulting daily activities.The patient also walks with a limp as the right leg is shorter than the left.Patient has continued physical therapy, but there has not been any change and the knee is not improving.Patient also had manipulation under anesthesia at some point after the knee replacement.The situation is ongoing.The patient is bilateral: the right prosthetic knee was implanted on 2022.
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Search Alerts/Recalls
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