Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Local Reaction (2035); Limited Mobility Of The Implanted Joint (2671)
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Event Date 01/02/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign report source: (b)(6).Concomitant medical products: unknown m2a cup.Unknown bimetric stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-04036.0001825034-2020-04037.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 that the patient was revised due to pain, difficulty ambulating, and adverse local tissue reaction approximately 7 years post implantation.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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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The event was confirmed with medical records received.Findings: six week visit denies pain.Still limps.Adequate rom.Limb lengths equal six month visit denies pain.Rarely/never limps.Adequate rom.Limb lengths equal one year visit denies pain.Rarely/never limps.Adequate rom.Limb lengths equal two year visit moderate - severe pain.Limping.Five year visit denies pain.Rarely/never limps.Adequate rom.Limb lengths equal ltfu revision due to armd (adverse reaction to metal debris) device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause was 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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Search Alerts/Recalls
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