MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 42MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number	74122542
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
Us legal.It was reported that, after a bhr-tha construct had been implanted on the patient¿s left hip on an unspecified date, the patient developed osteolysis around her pelvis and loosening of the acetabular component following a metallosis diagnosis.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.During this procedure, the posterior hip capsule had staining consistent with a gray metallosis, and the joint presented some grayish fluid and significant gray and black staining to the soft tissue.Some osteolysis along the posterior femoral shaft in the metaphyseal region was also noted.Upon removing the bhr modular femoral head and cup, the surgeon faced several difficulties whilst fixing a 56mm acetabular cup and was not satisfied with the outcome, as a properly fixation could had been compromised mainly due to the deficient condition of the medial, anterior and posterior wall of the acetabulum.Because of this, he decided to place the new implants and close the incision to further plan a caged reconstruction of the acetabulum.Patient¿s current health status is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that left hip revision surgery was performed due to osteolysis and metallosis.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the device.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints were identified for the hemi head.However, as the device is no longer sold, no action is to be taken.In the absence of the actual device, 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.A review of historic escalation actions related to the products 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 required.The available medical documents were reviewed.The clinical information provided of the gray and black staining to the soft tissue, grayish fluid, osteolysis, loose acetabular component, and bone deficiency 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.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, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
Additional Manufacturer Narrative
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 have not been returned for evaluation.Without definitive lot numbers a complete complaint history review cannot be performed for the devices involved.Should further details become available at a later date then the task will be reopened and completed.A review of the historical complaints data for the 74121342 modular head 42 mm -4 (short) and the acetabular cup was performed 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/reopen date.No other similar complaints were identified for the part numbers and the reported/related failure modes.However, as the devices are no longer sold, no action is to be taken.Without definitive lot numbers a complete complaint history review cannot be performed for the devices involved.Should further details become available at a later date then the task will be reopened and completed.As no device batch numbers were provided for investigation, manufacturing record review, device labelling / ifu review and historical review of the escalation actions could not be performed.If more information is received, this investigation will be reopened.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.The available medical documents were reviewed.The clinical information provided of the gray and black staining to the soft tissue, grayish fluid, osteolysis, loose acetabular component, and bone deficiency 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.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, 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 re-opened.Based on this investigation, the need for corrective and preventative actions is not indicated.
Additional Manufacturer Narrative
H3, h6.It was reported that left hip revision surgery was performed due to osteolysis and metallosis.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the device.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints were identified for the hemi head.However, as the device is no longer sold, no action is to be taken.As no device batch numbers were provided for investigation, a manufacturing record review could not be performed.If more information is received, this investigation will be reopened.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, 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 clinical information provided of the gray and black staining to the soft tissue, grayish fluid, osteolysis, loose acetabular component, and bone deficiency 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.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, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: HEMI HEAD 42MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14670396
• Report Number: 3005975929-2022-00395
• Device Sequence Number: 20475121
• Product Code: KWL
• UDI-Device Identifier: 00885556070710
• UDI-Public: 00885556070710
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 74122542
• Device Catalogue Number: 74122542
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 09/06/2022; 09/29/2022; 09/26/2022; 10/20/2022
• Initial Report FDA Received Date: 06/11/2022
• Supplement Report FDA Received Date: 09/13/2022; 09/30/2022; 10/19/2022; 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005975929-3/10/15-001
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female