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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Joint Dislocation (2374); Numbness (2415); Ambulation Difficulties (2544)
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Event Date 02/13/2011 |
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 evaluation, due to the implant remains implanted.The evaluation is in process.Once the evaluation has been completed, a follow-up mdr will be submitted.Maude report mw5073429.Product remains implanted.16-104150 ringloc+ shell lot # 847500.Multiple mdr reports were filed for this event.Please see associated reports: 0001825034-2018-00376, 00377.Remains implanted.
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Event Description
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It was reported a patient is experiencing worsening pain, a limp, ambulation difficulties, muscle spasms, muscle damage, and numbness from hip down to toes for the past 2 years.Patient also alleges that the hip "tried to dislocate" on two occasions.Patient reports being prescribed percocet for pain.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01649-1, 0001825034-2018-00377-2, 0001825034-2018-00376-2.
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Event Description
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It was reported that a patient started experiencing pain 4 years post implantation.The patient is experiencing worsening pain, a limp, ambulation difficulties, muscle spasms, muscle damage, and numbness from hip down to toes for the past 2 years.Patient also alleges that the hip "tried to dislocate" on two occasions.Patient reports being prescribed percocet for pain.
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Manufacturer Narrative
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Concomitant medical products: item# 11-363662, femoral head, lot# 047130.Item# 14-103201, taperloc stem, lot # 606010.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple reports were filed for this event, please see associated reports: 0001825034-2018-00376-1, 0001825034-2018-00377-1, 00018.
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Event Description
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It was reported that a patient started experiencing pain 4 years post implantation.
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Search Alerts/Recalls
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