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Us legal, it was reported that the plaintiff underwent a conversion surgery of the left hip on (b)(6) 2009, 10 days after the primary resurfacing surgery was performed.The revision surgery was performed due to a femoral head fracture and the resurfacing system was converted to a bhr tha system.The patient was sent to the recovery room in stable condition.Then, the patient suffered other complications requiring a second revision surgery.
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H3, h6: it was reported that a left hip conversion surgery was performed 10 days after the primary left hip surgery.During the revision, the femoral head was explanted.The acetabular cup remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint bust has not become available.A review of the historical complaints data for the femoral head was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.No other similar complaints were identified to involve this batch of femoral heads.Two other similar complaints were identified to involve this batch of acetabular cups, however, as one of these relates to the same patient and the device is no longer sold, no action is to be taken.No other similar complaints have been identified for the part numbers and the reported failure modes in this timeframe.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.Review of manufacturing records did not reveal any waivers, concessions, manufacturing, or material abnormalities that could have contributed to this issue.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A review of the product drawings for the femoral head was performed.The review did not reveal any product dimension or feature abnormalities which could have contributed to this issue.The devices used in treatment have been phased out from the market and as a result there is no live product specification file or live risk management file to review.A review of escalation actions related to the products and similar complaints was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible; the listed batches were manufactured before the corrective actions¿ implementation, no further escalation actions required.The available medical documents were reviewed.With the limited information provided, the clinical root cause of the reported femoral head fracture of the bhr component cannot be confirmed.It cannot be concluded that the reported event was associated with mal performance of the implant.The patient impact beyond revision and expected transient post-op convalescence period cannot be determined.Without return of the devices used in treatment or additional information we cannot advance the investigation or confirm this complaint; our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the information provided, factors known to contribute to the alleged fault include excessive physical activity levels and trauma to the joint replacement.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
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