SMITH & NEPHEW, INC. UNKN CHS COMPRESSION HIP SCREW SCREW; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYA
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Catalog Number UNKN02200503 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Necrosis (1971)
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Event Date 12/01/1995 |
Event Type
Injury
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Event Description
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On the literature review "fixation of femoral neck fracture: a randomized 2-year follow-up study of hook pins and sliding screw plate in 222 patients", it was reported that fourteen (14) patients who underwent primary implantation with a sliding screw and plate to treat a cervical hip fracture, experienced a postoperative femoral head collapse.From these, four (4) underwent revision surgery to implant an unspecified endoprosthesis in exchange.The outcome of these patients is not known.No further information is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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H10: the devices were not returned for evaluation and the reported events could not be confirmed.The clinical/medical investigation concluded that, per the complaint, no further information is available.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patients outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported events include excessive forces applied to implant and patients condition.The contribution of the devices to the reported events could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products 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.We consider this investigation closed.Internal complaint reference number: (b)(4).
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