Model Number N/A |
Device Problem
Noise, Audible (3273)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Pain (1994); Swelling (2091); Burning Sensation (2146); Joint Swelling (2356); Ambulation Difficulties (2544); No Code Available (3191)
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Event Date 06/30/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown vanguard cr articular surface catalog # unknown lot # 243670, biomet cc cruciate tray catalog # 141233 lot # j3506997, biomet series a standard patella catalog # 184766 lot # 049600, cement bone simplex catalog # 6191-1-001 lot # rcv037, cement bone simplex catalog # 6191-1-001 lot # rjv119, unknown catalog # unknown lot # 808860.Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2018-02462, 0001825034-2018-02466, 0001825034-2018-02472.Product location is unknown.
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Event Description
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It was reported that the patient underwent an initial knee arthroplasty.Subsequently, the patient suffered pain, stiffness, hypertension & cold sensation in the knee.There was a popping noise in the knee with burning sensation.The patient has reported difficulty in walking without a walker.
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Manufacturer Narrative
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The additional information received does not change any previously reported investigation results.
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Event Description
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No additional information is available at this time.
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Event Description
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No additional information is available to report at this time.
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Manufacturer Narrative
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The follow up report is being submitted to relay additional information received.The complaint cannot be confirmed based as no medical records were provided.The device history records were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b5; d7.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 underwent initial knee arthroplasty.Subsequently, the patient was revised approximately 4 years post implantation due to chronic pain, cold sensation, hypertension, stiffness and swelling in the knee.The patient also experienced a popping noise in the knee with burning sensation.The patient reported difficulty due to hyper extension and cannot walk without a walker.
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Search Alerts/Recalls
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