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Catalog Number 74122546 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Metal Related Pathology (4530)
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Event Date 08/04/2020 |
Event Type
Injury
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Event Description
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''us legal mdl'': it was reported that, after a primary bhr-tha construct had been implanted on the plaintiff's right hip on (b)(6) 2006, the plaintiff experienced severe pain, limited mobility and metallosis.A revision surgery was performed on (b)(6) 2020 to treat this adverse event.The plaintiff's outcome is unknown.
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Event Description
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It was reported that, after a primary bhr-tha construct had been implanted on the plaintiff's right hip on (b)(6) 2006, the plaintiff experienced severe pain, limited mobility and metallosis.A revision surgery was performed on (b)(6) 2020 to treat this adverse event.The femoral head was explanted, and the cup was left in the patient.During the revision, significant bone erosion was noticed, and a gross area of the stem was no longer covered, therefore it was also explanted.The plaintiff's outcome is unknown.
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Manufacturer Narrative
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Sections a2, a3, b5, d3, d4, d10 and h4 were updated with the new information received.Internal complaint reference number: (b)(4).Section d1 and d2 was corrected according to the new information received.
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Manufacturer Narrative
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H3, h6: it was reported that right hip revision surgery was performed.During the revision, both the hemi head and the stem were 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 but has not become available.A review of the historical complaints data for the hemi head, acetabular cup and modular sleeve was performed; using batch numbers to evaluate patterns of repeated failures or defects over the lifetimes of the products 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.Following the review, no other similar complaints were identified to involve these batches of hemi heads or modular sleeves.Other similar complaints were identified to involve this batch of acetabular cups and other similar complaints have been identified for the part number and the reported failure mode in this timeframe, and this failure will continue to be monitored.Regarding the hemi head, other similar complaints have been identified for the part number and the reported failure mode in this timeframe.However, as the device is no longer sold, no action is to be taken.A review of complaint history did not reveal additional complaints for the stem.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.No further actions are required at this time.The available medical documents were reviewed.The clinical information provided of the reported pain, limited mobility, and significant bony erosion may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.Further, it cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant.Without the 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 limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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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Search Alerts/Recalls
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