SMITH & NEPHEW, INC. UNKN R3 IMPLANT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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Catalog Number UNKN01100900 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thromboembolism (2654)
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Event Date 08/01/2009 |
Event Type
Injury
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Event Description
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*literature case* "mid-term clinical results of the cementless r3 cup and polarstem total hip arthroplasty".Author: ali assaf et al., european journal of orthopaedic surgery & traumatology (2019).It was documented on the paper that there was a patient who developed a thromboembolic event.The patient had a deep venous thrombosis in the operated limb in the third week post-operatively.The patient was receiving oral anticoagulation therapy as per hospital protocol.
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Manufacturer Narrative
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It was reported from a literature review that the patient had a deep venous thrombosis in the operated limb in the third week post-operatively.The patient was receiving oral anticoagulation therapy as per hospital protocol.The affected device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Some potential causes of the reported event could include but not limited to patient medical conditions, surgical technique or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
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