| Model Number N/A |
| Device Problems
Break (1069); Fracture (1260)
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| Patient Problems
Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)
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| Event Date 10/15/2019 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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Event Description
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Report of a revision due to a fracture insert (oxford) 17 years post-operative.
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Event Description
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It was reported that a revision procedure was performed due to implant fracture 17 years post-operative.Additional information: notification date (when zimmer biomet becomes aware of event): (b)(6) 2019.Date when event occurred: (b)(6) 2019.Date implanted: 2002.Date explanted: (b)(6) 2019.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.Due to circumstances surrounding the covid-19 pandemic, complaint product evaluation cannot be performed at this time.We have however received xrays with regard to this matter and these have been reviewed given the information available at this time.The complaint investigation has proceeded with currently available information, xray review, manufacturing history review and complaint history review.Four radiographs were provided with (b)(4) for analysis.The dates on the radiographs indicate that two radiographs (one mediolateral and one anteroposterior) were taken on (b)(6) 2006, about 4 years after primary surgery; the other two radiographs (one mediolateral and one anteroposterior) were taken on (b)(6) 2019, about 17 years after the primary surgery.Both anteroposterior radiographs show the presence of the marker wire between the femoral component and tibial tray.However, the orientation of the knee in the 2019 radiograph does not allow to determine of the position of the polyethylene meniscal bearing or to assess the gap between the femoral component and tibial tray.Osteophytes or extruded bone cement may be present medially to the tibial tray.The gap between the femoral component and tibial tray appears to be reduced in the mediolateral radiograph taken in 2019 compared to the mediolateral radiograph taken in 2006.The x-ray marker wire and balls are not visible in both mediolateral radiographs.Therefore, positioning of the polyethylene meniscal bearing cannot be evaluated from these radiographs.The mhr related to the involved product has been reviewed and does not show any non-conformity, rejection or concession that could be related to the reported event.It was reported that the implant was in use for approximately 17 years, before the fracture of the polyethylene meniscal bearing was reported and the bearing was revised.Without the opportunity to examine the revised component and without provision of further radiographic, surgical and patient information, the fracture of the polyethylene meniscal bearing cannot be confirmed and the root cause for its failure cannot be determined in this instance.A review of the complaint database over the last 3 years has found no similar complaints reported with this item 154634.Once we are in a position to evaluate the product, we will immediately re-open the complaint and add the additional information which we may obtain from any visual, dimensional and analysis of the fracture.
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Event Description
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It was reported that a revision procedure was performed due to implant fracture 17 years post-operative.Additional information: notification date (when zimmer biomet becomes aware of event): (b)(6) 2019.Date when event occurred: (b)(6) 2019.Date implanted: 2002.Date explanted: (b)(6) 2019.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b1, b4, b5, d10, g3, g4, g5, g7, h1, h2, h3, h6, h10.The product has been returned to zimmer biomet for investigation.Date implanted: 2002.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : evaluation anticipated but not yet begun.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.Products have been returned to biomet uk ltd for evaluation and forwarded to the product evaluation complaints engineer for investigation.An oxford meniscal bearing was revised after approximately 17 years due to fracture.The available relevant manufacturing history records indicate that the item was manufactured and sterilised in accordance with the applicable specifications.A review of the complaint database over the last 3 years found no other complaints for item 154634 other than (b)(4).The revised meniscal bearing shows evidence of delamination, cracking and plastic deformation, which indicate that the bearing was subject to elevated stresses, likely due to adverse loading and impingement.Visual examination, radiographic examination and the measured linear wear rate from the posterior edge of the bearing suggest that the elevated stresses may have led to adverse wear and ultimately contributed to the fracture of the bearing in this instance.Given such adverse loading conditions and impingement, evidence suggests that the bearing performed to an acceptable level.Other contributing factors cannot be discussed without further information such as immediate post-primary radiographs and patient or surgical information.The available mhr reviews indicates that the product was most likely conforming to design specification when it left zimmer biomet control, however it is not possible to confirm the root cause of the revision with the information available.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Risk assessment: the event reports revision due to fractured insert.Risk management file documents the estimated residual risk associated with the reported event.Failure analysis report concludes: an oxford meniscal bearing was revised after approximately 17 years due to fracture.The reported event states revision due to fractured insert.A line in the risk file for excessive wear of articulating surfaces relates to the reported event.This line has a severity score of 4 defined in the rmr as results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention.Therefore, the reported event is in line with the risk file.The outcome of this complaint is considered to be within the severity of the rmr.In order to calculate the occurrence rate, sales and complaint data for this item number have been obtained, and are attached for a period of the last 3 years prior to notification date, being oct 2019.Sales (oct 2016 to oct 2019) = (b)(4) units.Complaints search was conducted for events occurring between (b)(6) 2016 to (b)(6) 2019 for item 154634.No other complaints were identified for this item number other than (b)(4).Therefore, the calculated occurrence rate is 1 in 83 or 1.2 percent.Since the occurrence calculation is based on only 1 complaint, the current occurrence ratings in the risk management file are still relevant and have not been exceeded; as it is not possible to make a calculation based on one instance of a complaint.The failure mode will be monitored through zimmer biomet¿s internal complaint and post market surveillance activities with further review of risk conducted through these processes.If further information regarding the root cause of the reported event are provided risk should be re-assessed.
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Event Description
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Report of a revision due to a fracture insert (oxford) 17 years post-operative.Additional information: notification date (when zimmer biomet becomes aware of event): (b)(6) 2019.Date when event occurred: (b)(6) 2019.Date implanted: 2002.Date explanted: (b)(6) 2019.
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Search Alerts/Recalls
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