SMITH & NEPHEW, INC. UNKN CHS COMPRESSION HIP SCREW PLATE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Deformity/ Disfigurement (2360)
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Event Date 10/09/1988 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: case-(b)(4).Ingemar sernbo, olof johnell, carl-frederik gentz, jan-aake nilsson.(1998).Unstable intertrochanteric fractures of the hip: treatment with ender pins compared with a compression hip-screw.The journal of bone and joint surgery.
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Event Description
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It was reported that on literature review "unstable intertrochanteric fractures of the hip: treatment with ender pins compared with a compression hip-screw.", four (4) patients who underwent primary implantation with a compression hip screw + plate for treatment of unstable intertrochanteric fractures, experienced varus deformity.Three (3) of these patients reported a deformity of more than ten (10) degrees, and the remaining patient experienced a deformity of more than twenty (20) degrees.It is not known if any measures were taken to resolve these deformities.No further information is available.
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Manufacturer Narrative
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Section h10: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that there is no contact information available for this literature case; therefore, patient specific supporting documentation or current patient status has not been provided as of the date of this medical investigation.The images provided in the article have been interpreted within the text; therefore, no further analysis of the imaging is required.The clinical root cause of the reported events cannot not be further assessed.The patient¿s outcome beyond that which was documented in the article cannot not be determined as the patient¿s current health status remains unknown.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication or patient medical history.The contribution of the devices 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 devices 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.Internal complaint reference number: (b)(4).
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