Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)
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Event Date 01/06/2021 |
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 device remains implanted.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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It was reported patient is experiencing trochanteric bursitis and is unable to bear weight approximately three months post implantation.Attempts to obtain additional information have been made; however, no more is available at this time.
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Manufacturer Narrative
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(b))(4).D10: acetabular cup 010000664, lot 6840429 acetabular liner 20113606, lot 64617991 femoral head 6500660, lot 3030957 g2: mymobility clinical study: 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.
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Event Description
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It was reported that the patient had an initial right tha and within three months was experiencing trochanteric bursitis and is unable to bear weight.The patient continued to experienced moderate-severe pain at the three month follow up leading to mri and aspiration of the right hip.Results/outcome pending.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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Reported event was confirmed by review of medical records noting patient presented with pain while bearing weight.Trochanteric bursitis was noted along with numbness lateral to incision.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.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.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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