Catalog Number 00801802814 |
Device Problems
Material Erosion (1214); Unintended Movement (3026); Noise, Audible (3273)
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Patient Problems
Pain (1994); Tissue Damage (2104); Patient Problem/Medical Problem (2688)
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Event Date 12/04/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 00771101520/ femoral stem neck taper/ lot # 61712783.Item # 00875801228 / liner/lot # 61675526.Item# 00875705601/ shell/ lot# 61903786.Item # 00625006540/bone screw /lot # 62462616.Item # 00625006530 bone screw/ lot # 61911788.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2020 -01298, 0001822565 -2020 -01301, 0001822565 -2020 -01302.
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Event Description
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It was reported patient underwent hip revision surgery 4 years post implantation due to pain and squeaking.During the revision, metal debris was noted from the femoral neck impinging on the metal ring of the locking liner.The shell, head, and liner were replaced without complication, and another attempt to repair the abductors was made.Attempts have been made and additional information on the reported event is unavailable at this time.
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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 (b)(4).
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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 (b)(4).
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Search Alerts/Recalls
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