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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544)
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Event Date 02/12/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant products: cat#22-300916; lot#379520 - arcos 16 x 190 mm spl tpr dist ha, cat#650-0840; lot#2754109 - 36 mm cocr biomet fem hd -3 nk, cat#pt-106056; lot#389700 - regen/rnglc+ multi 56 mm sz 24, cat#ep-105894; lot#427480 - ringloc 36 mm epoly lnr 10 deg sz24, cat#350806; lot#283490 - 2.0 mm ss cable/sleeve combo, cat#350806; lot#203530 - 2.0 mm ss cable/sleeve combo, cat#350806; lot#111410 - 2.0 mm ss cable/sleeve combo.Report source: foreign.The event occurred in (b)(6).This report is being submitted late as it has been identified in remediation.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 as no were trends identified.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.Related mfr reports: 0001825034-2017-10931, 0001825034-2017-10932, 0001825034-2017-10934, 0001825034-2017-10935, 0001825034-2018-08664, 0001825034-2018-08665.
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Event Description
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It was reported that the patient underwent initial right hip surgery on an unknown date and was revised due to loosening (b)(6) 2014.Subsequently patient experienced problems walking about, problems washing or dressing, moderate pain (may take aspirin), a moderate limp, moderate trouble getting in or out of the car, moderate difficulty putting on socks, noted it was impossible to shop, extremely difficult to climb stairs, moderately painful to stand up, and unable to perform usual activities at 3 year follow up visit on (b)(6) 2016.The patient was also using 2 crutches or a walker at the 3 year visit.
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Search Alerts/Recalls
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