Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Insufficient Information (3190)
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Patient Problems
Damage to Ligament(s) (1952); Pain (1994); Tissue Damage (2104)
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Event Date 02/01/2016 |
Event Type
Injury
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Event Description
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It is reported that the patient is experiencing pain after a knee arthroplasty.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Brand name - tibial component precoat right medial/left lateral size 3.Common device name - hsx.Model #/lot # ¿ catalog 00584200302 lot 62802366, exp aug 31, 2024.Implant date ¿ (b)(6) 2014.Concomitant medical products ¿ (b)(6) 2016.Date received by mfr.- jun 27, 2017.Pma - k033363.Device manufacture date - sep 15, 2014.(b)(4).Concomitant medical products- femoral component catalog 00584201402 lot 62761646; articular surface size 3 9 mm height catalog 00584209309 lot 62482647.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed through receipt of mri report.Product was not returned for evaluation.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.A definitive root cause cannot be determined with the information 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.
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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.Corrected: date received by mfr - initial ( jan.3, 2017).
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Search Alerts/Recalls
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