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It was reported that, a left bhr primary surgery was performed on (b)(6) 2008.A revision surgery was later carried out on (b)(6) 2014, because the plaintiff experienced clicking and catching of the implants and pain; and was diagnosed with elevated metal ions and a pseudotumor.During surgery copious metal stained fluid and tissue near the pseudocapsule was found.Both bhr components were exchanged for s+n implants, and the patient was taken to recovery in stable condition.Further complications have not been reported.
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It was reported that, a left bhr primary surgery was performed.A revision surgery was later carried out because the patient experienced clicking and catching of the implants and pain; and was diagnosed with elevated metal ions and a pseudotumor.During surgery copious metal stained fluid and tissue near the pseudocapsule was found.Both bhr components were exchanged for s+n implants, and the patient was taken to recovery in stable condition.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the alleged devices was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the cup and head, and this failure will continue to be monitored.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.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.The clinical root cause for the ¿heterotopic ossification¿ cannot be concluded but some patients can be genetically predisposed it is a known complication of joint surgeries and is related to the procedure and not the device.The reported pain, elevated metal ions, pseudotumor and metal-stained fluid and tissue are consistent with findings associated with metal debris; however, with the limited information provided the clinical root cause of the reported clinical reactions cannot be confirmed.It cannot be concluded that the reported events/clinical reactions were associated with a mal performance of the implant.The patient impact is the pain, revision, and expected transient post-op convalescence period.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.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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