SMITH & NEPHEW, INC. SYN POR FEM COMP SZ 16; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL,
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Model Number 71306616 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994)
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Event Date 02/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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Internal reference: (b)(4).
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Event Description
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It was reported that, 3 moths after a left revision surgery performed in (b)(6) 2015 (captured under (b)(4)), the patient experienced pain on the area.The physician diagnosed traumatic bursitis, which was treated with some physical therapy and ultrasound treatment.No other complications were reported.
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Manufacturer Narrative
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The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the reported post-revision pain is associated with the patient¿s bursitis and/or implant size and is not associated with a malperformance of the implant but is likely due to the ¿large pin¿ as reported.The patient impact cannot be determined.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 not limited to traumatic injury, joint tightness, material in use or patient reaction.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.Additional information: d3.
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