Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544)
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Event Date 09/27/2012 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: 13-104156 item name m/h 3hole rlc shl nrs 56mm/l24 lot # 877600; ep-105994 item name epoly 36mm rlc lnr mrom sz24 lot # 738730; 11-363662 item name 36mm cocr mod hd std lot number # 239080.Multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2024 - 00014; 0001825034 - 2024 - 00015; 0001825034 - 2024 - 00016.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device location is unknown.
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Event Description
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It was reported that 10 months post implantation the patient reported experiencing right hip and groin pain for 6 months.The pain was affecting his ambulation and daily activities.Prescription pain medication and an assistive device along with a bone scan to further assess this was recommended.The bone scan was consistent with degenerative changes.One year later, the patient presented with some pain again however no prescription measures were recommended as treatment and resolved on it's own.There is no additional information available at this time.
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Event Description
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There is no update to the prior event description provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6 component code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on the evaluation of the provided medical records.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient reported pain in the groin and r thigh with increased activity.Pain greater than 6 months post-op which limited the patient¿s activities and ability to ambulate as well as required prescription pain medication to resolve.A definitive root cause cannot 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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