Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Hematoma (1884); Loss of Range of Motion (2032); Scar Tissue (2060); Joint Dislocation (2374); Muscle/Tendon Damage (4532)
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Event Date 10/28/2021 |
Event Type
Injury
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Event Description
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It was reported the patient underwent initial left hip hemiarthroplasty.The patient was converted to a total hip arthroplasty approximately 3 years later.The patient underwent head and liner exchange approximately 6 months later to recurrent dislocations.The patient was revised again approximately 3 weeks later due to recurrent dislocations and psoas tendon rupture.The head and liner were exchanged without complication.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).Concomitant products: ref 110010245 lot 64866560 shell; ref 00-7850-013-00 lot 63992895 femoral stem.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 03250.
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Manufacturer Narrative
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Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 1822565.
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Event Description
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Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 1822565.
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Search Alerts/Recalls
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