Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).D10: cat# 010000925 lot# 7360776 g7 hi-wall e1 liner 32mm c; g2: foreign: country: china; customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2024-00679.
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Event Description
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It was reported that during a right hip replacement surgery the liner would not fit into the cup.The surgeon polished the acetabulum according to the routine operation.A 48mm c acetabular cup was selected for implantation, with a 32mm c liner.The liner was unable to fit into the acetabular cup.After several unsuccessful attempts, the surgeon chose to implant a larger acetabular cup and liner.There was an approximate 35-minute delay.No additional information available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and corrected information.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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Additional information received.Although it was initially reported that a larger cup and liner were implanted, it was since determined that the larger cup and liner were not actually used.Instead, the cup and liner that would not lock were soaked in cold water for 10-minutes, and then the products were successfully implanted.There was not a 35-minute delay as initially reported, there was actually a 15-minute delay due to the soak.No additional information available.
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Search Alerts/Recalls
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