|
Catalog Number 74122552 |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 07/13/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Internal complaint reference (b)(4).
|
|
Event Description
|
It was reported that, after undergoing left hip bhr surgery on (b)(6) 2009 in which an unknown bhr cup and modular femoral head were implanted, the patient experienced unspecified complications.This adverse event was treated by performing a revision surgery on (b)(6) 2022.The patient subsequently presented additional unspecified adverse events that were treated by performing posterior capsule mesh reconstruction on (b)(6) 2022 (documented under case-2023-00142670).
|
|
Manufacturer Narrative
|
H6: medical device problem code section h3, h6:it was reported that a left hip revision surgery was performed due to unspecified metal-related complications.As of today, the implanted devices, all of which were used in treatment are not accessible for testing.As no device part and batch numbers were provided for investigation for any of the 3 devices, a complaint history review, manufacturing record review, or definite escalation actions review could not be performed.If more information is received, this investigation will be reopened.The review of the product's current ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed for the reported metal-related complications.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 for all hemi heads and sleeves and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.As no device part and batch numbers were provided for the cup, a escalation actions review could not be performed.The available medical documents were reviewed.Based on the reported symptoms it cannot be concluded that the reported event/clinical reaction (unspecified metal-related complications) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.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.
|
|
Manufacturer Narrative
|
B4 - describe event or problem - it was reported that, after undergoing left hip bhr-tha surgery on (b)(6) 2009, the patient experienced unspecified metal-related complications.This adverse event was treated by performing a revision surgery on (b)(6) 2022.Additionally, on (b)(6) 2022, the patient underwent a posterior capsule mesh reconstruction to repair extensive damage to the hip.D1 - brand name ¿ unknown birmingham hip modular head (bhmh) hemi.D2a product code ¿ kwl.D2b common device name - prosthesis, hip, hemi-, femoral, metal.
|
|
Event Description
|
It was reported that, after undergoing left hip bhr-tha surgery on (b)(6) 2009, the patient experienced unspecified metal-related complications.This adverse event was treated by performing a revision surgery on (b)(6) 2022.Additionally, on (b)(6) 2022, the patient underwent a posterior capsule mesh reconstruction to repair extensive damage to the hip.
|
|
Event Description
|
It was reported that, after undergoing left hip bhr-tha surgery on (b)(6) 2009, the patient experienced unspecified metal-related complications.This adverse event was treated by performing a revision surgery on (b)(6) 2022.
|
|
Manufacturer Narrative
|
H10: additional information was added in b5, d1, d4, d10, and h4.
|
|
Manufacturer Narrative
|
H3, h6: it was reported that, after undergoing left hip bhr-tha surgery, the patient experienced unspecified metal-related complications.As of today, the devices, which were used in treatment, have not been returned for evaluation.A review of the historical complaints data for the hemi head, modular sleeve and bhr cup 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.Similar complaints have been identified and this will continue to be monitored through routine monthly trending, it should be noted that the sleeve and head are no longer sold.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.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 quality escalations was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible; no further escalation actions required.The available medical documents were reviewed.The reported increasing metal levels and pain, pseudotumor, and corrosion material and debris around the taper and in the taper sleeve may be consistent with the reported adverse local reaction.However, the clinical root cause of the reported events/clinical reactions cannot be confirmed, and it cannot be concluded that the reported events/clinical reactions were associated with a mal performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the information provided we cannot further investigate the complaint 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, loosening of components may increase production of wear particles and accelerate damage to the bone.If the products or additional information become available in the future, this case will be reopened.Based on this investigation the need for corrective and preventative action is not indicated.
|
|
Search Alerts/Recalls
|
|
|