Bilateral patient.Plaintiff underwent medically-indicated two-stage revision of the bhr-tha left hip implants on (b)(6) 2018.(1st stage) and (b)(6) 2019 (2nd stage).During the second stage the zimmer stem was removed again along with the bhr-tha shell, head and sleeve.The patient revision surgery was performed due to severe pain, limited mobility, metallosis, pseudotumor formation, and elevated cobalt and chromium ion levels.No s&n parts remained implanted.
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H3, h6: it was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup, hemi head, modular sleeve and synergy stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the stem.Similar complaints have been identified for the stem, this will continue to be monitored.Similar complaints have been identified for the cup and head.However, as the devices are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.It was also confirmed that all devices were sterilised.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.The root cause of the first three revisions from the multiple dislocations cannot be concluded.It is unknown what impact the reported infection, the scar tissue and the it band, (on the left atrophied, and a hole in it on the right), had on the dislocations.For the bilateral two stage revisions; the clinical information provided, of the reported elevated metal ion levels, the pseudotumor, and the necrotic tissue may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure versus the reported infection.The cultures that tested positive for bacillus species on the left and mrse on the right were likely an hematogenous infection.The impact to the patient was long term pain with multiple surgeries and recoveries to go through.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, our investigation remains inconclusive and a definitive root cause cannot be determined.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
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