MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74121150

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Injury (2348); Metal Related Pathology (4530); Unequal Limb Length (4534)

Event Date 04/02/2017

Event Type  Injury  

Event Description

It was reported that, after a bhr construct had been implanted in a right hip arthroplasty, the patient experienced pain, limited mobility, and elevated metal ion levels.A medically-indicated revision surgery was performed to treat the adverse event.The patient outcome is unknown.

Manufacturer Narrative

It was reported that right 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.As no device details have been made available for this complaint, no documentation review could be performed.However, all released devices would have met manufacturing specifications at the time of production.The available medical documents were reviewed.The revision document does not note findings consistent with the reported aseptic loosening of femoral and acetabular implants.The root cause of the reported pain, limited mobility and elevated metal ions cannot be confirmed and it cannot be concluded that the reported 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.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.

Manufacturer Narrative

H10: a1 a2 a3 b3 b5 b6 d1 d4 h6 (health effect - clinical code & medical device problem code).

Event Description

It was reported that, after a bhr construct had been implanted in a right hip arthroplasty, the patient experienced pain, slightly shortened right lower extremity compared to the left, limited mobility, and elevated metal ion levels.A medically-indicated revision surgery was performed to treat the adverse event.The patient outcome is unknown.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: it was reported that 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.As no device part and batch numbers were provided for investigation for the acetabular cup, a complaint history review, 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.A review of the historical complaints data for the 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 complaints were identified to involve this batch.Other similar complaints were identified for the part number and the reported/related failure mode.This will continue to be monitored.¿ in the absence of the actual devices, the production records were reviewed for the femoral head reportedly involved in this incident.All the 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 x-ray report and revision document does not note findings consistent with the reported aseptic loosening of femoral and acetabular implants.The root cause of the reported pain, limited mobility and elevated metal ions cannot be confirmed, and it cannot be concluded that the reported 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 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 reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

Manufacturer Narrative

D4: device expiration date and h5: device manufactured date d4: lot#.

Manufacturer Narrative

H10 - additional information a4 - patient weight b6 - relevant tests b7 - other relevant history.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to pain, leg length discrepancy, limited mobility, and elevated metal ion levels.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 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 complaints were identified to involve this batch.Other similar complaints were identified for the part number and the reported/related failure mode.This will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the femoral head.All the 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 x-ray report and revision document does not note findings consistent with the reported aseptic loosening of femoral and acetabular implants.The root cause of the reported pain, limited mobility and elevated metal ions cannot be confirmed, and it cannot be concluded that the reported 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 available 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 reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: RESURFACING FEMORAL HEAD 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• 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: sarah freestone ; aurora house; spa park; leamington spa, warwickshire ; 4414826737
• MDR Report Key: 10115091
• MDR Text Key: 193668569
• Report Number: 3005975929-2020-00179
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Model Number: 74121150
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 76702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 66 KG