SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Model Number 74121150 |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Metal Related Pathology (4530); Unequal Limb Length (4534)
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Event Date 11/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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Complaint reference: case-(b)(4).
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Event Description
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It was reported that the patient underwent a bhr revision surgery to a tha conversion.The patient presented elevated ion levels, cobalt 13.5 ppm and chromium 5.0ppm.The patient outcome is unknown.
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Manufacturer Narrative
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It was reported that 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 and bhr head 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 head and cup.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.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.Smith and nephew has not received the explanted device/ adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.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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Manufacturer Narrative
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H10.Additional information in a1, a2, a3, b5, b6, b7 and h6 (updated medical device problem code).H11.Corrected information in d6a.
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Event Description
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It was reported that the patient underwent a bhr revision surgery to a tha conversion due to metallosis.During the revision, some gray fluid was found in the joint.The metallic femoral head was explanted, while the cup was left in place.The patient outcome is unknown.
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Manufacturer Narrative
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H3, h6: it was reported that a right hip revision surgery was performed.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 acetabular cup and 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 prior 12 months as of the complaint aware date.No other similar complaints were identified to involve this batch for the acetabular cup and femoral head.Other similar complaints were identified for the part number and the reported failure mode for the acetabular cup and the femoral head this 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.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.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 gray fluid and metallic staining is consistent with the reported metallosis.However, the ¿neutral position¿ of the acetabular cup, ¿on account of his preexisting significant and substantial posterior pelvic tilt and exposed metal in the superior-anterior, region of the psoas tendon,¿ cannot be ruled out as contributing factors of the reported metallosis and subsequent revision.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and 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, positioning failure of the device, 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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