SMITH & NEPHEW, INC. UNKN R3 SHELL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 08/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Yeroushalmi, d., singh, v., maher, n., gabor, j.A., zuckerman, j.D., & schwarzkopf, r.(2021).Excellent mid-term outcomes with a hemispheric titanium porous-coated acetabular component for total hip arthroplasty: 7¿10 year follow-up.Hip international, 11207000211040181.Doi: doi.Org/10.1177/11207000211040181.
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Event Description
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It was reported that on literature review "excellent mid-term outcomes with a hemispheric titanium porous-coated acetabular component for total hip arthroplasty: 7¿10 year follow-up" one patient suffered from a surgical site infection (ssi) at postoperative day #507, after undergoing a primary tha using the r3 acetabular system.The patient was treated with 2 stage revision surgery.The outcome of the patient is unknown.No further information is available.
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Manufacturer Narrative
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The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint details, no further clinical information if available.Subsequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient 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.Should any additional relevant patient information be provided, this case would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.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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