Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 12/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Reviewing policy regarding release of the explanted products.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product has not been returned.
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Event Description
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It was reported that the patient underwent oxford knee surgery on (b)(6) 2020.Subsequently a revision was performed on (b)(6) 2020 due to infection.Bearing was replaced during this revision procedure.Oxford warranty coverage requested by surgeon.
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Event Description
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It was reported that the patient underwent oxford knee surgery on (b)(6) 2020.Subsequently a revision was performed on (b)(6) 2020 due to infection.Bearing was replaced during this revision procedure.Oxford warranty coverage requested by surgeon.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: operative notes received (under review).Patient information received: date of birth: (b)(6) 1949, age: 71 years.The investigation is in process.Once the investigation has been completed, a supplemental mdr will be submitted.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found one complaint((b)(4)) reported with the item 159542.Risk assessment: root cause: risk management report documents the estimated residual risk associated with cemented oxford partial knee system.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.Between 29 december 2017 and 29 december 2020: number of similar incidents identified: (b)(4).Occurrence rate assessment for item 159542 29 december 2017 to date of notification, 29 december 2020: (b)(4) items were sold.Therefore, the calculated occurrence rate is (b)(4).Risk statement: the reported event states that the revision was performed due to infection.Although the root cause could not be determined, infection is captured multiple times within the oxford cemented implant risk table with a severity score no greater than 4 (critical).The outcome of the reported event (surgical intervention) is considered to be within the severity of the rmf.If further information regarding the root cause of the reported event is provided, risk should be re-assessed.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
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Event Description
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Patient underwent oxford knee surgery on (b)(6) 2020.Subsequently a revision was performed on (b)(6) 2020 due to infection.Bearing was replaced during this revision procedure.Oxford warranty coverage requested by surgeon.
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Search Alerts/Recalls
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