MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL

Catalog Number 74120158

Device Problems Biocompatibility (2886); Compatibility Problem (2960)

Patient Problems Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Injury (2348); Neuralgia (4413); Metal Related Pathology (4530)

Event Date 11/04/2019

Event Type  Injury  

Event Description

*us legal mdl* it was reported that a revision surgery was performed on the patient right hip due to persistent hip pain and limitations of day to day living, elevated chromium and cobalt levels and concern for metallosis.Among the intra-operative findings was presence of synovitic-type darkish stained tissue consistent with metal on metal wear from a failed left hip resurfacing arthroplasty.The patient outcome is unknown.

Manufacturer Narrative

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.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

H3, h6: it was reported that a revision surgery was performed on the patient right hip.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 complaint history for the bhr head and cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.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's instructions for use 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 medical documents were reviewed.In conclusion, the clinical information provided, the reported elevated metal ion levels, the dark stained tissue and pain, 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.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

H3, h6: it was reported that a right hip revision surgery was performed due to hip pain and limitations of day to day living, elevated chromium and cobalt levels and concern for metallosis.Among the intraoperative findings was presence of darkish stained tissue.As of today, the implanted device used in treatment has not been returned for evaluation.A review of the historical complaints data for the acetabular cup was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for device, and this failure will continue to be monitored.In the absence of the actual device, the production records were reviewed for the device reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The 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 product and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.It should be noted the patient¿s contralateral implant from another manufacturer cannot be ruled out as a contributing factor to the reported clinical reactions.The clinical information provided, the reported elevated metal ion levels, the dark stained tissue and pain, may be consistent with a reaction to metal debris.However, the source and the clinical root cause cannot be determined with the available documentation.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.

Event Description

It was reported that a revision surgery was performed on the patient right hip due to persistent hip pain and limitations of day to day living, elevated chromium and cobalt levels and concern for metallosis.Among the intra-operative findings was presence of synovitic-type darkish stained tissue consistent with metal on metal wear from a failed right hip resurfacing arthroplasty.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that a right hip revision surgery was performed due to hip pain and limitations of day to day living, elevated chromium and cobalt levels and concern for metallosis.Among the intraoperative findings was presence of darkish stained tissue.As of today, the implanted device used in treatment has not been returned for evaluation.A review of the historical complaints data for the acetabular cup was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for device, and this failure will continue to be monitored.In the absence of the actual device, the production records were reviewed for the device reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The 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 product and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.It should be noted the patient¿s contralateral implant from another manufacturer cannot be ruled out as a contributing factor to the reported clinical reactions.The clinical information provided, the reported elevated metal ion levels, the dark stained tissue and pain, may be consistent with a reaction to metal debris.However, the source and the clinical root cause cannot be determined with the available documentation.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 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 information: d8, g3/g4 (pma/510(k)number), h4.Corrected data: b5, e1 ( initial reporter name and address), g2, h6 (health effect - clinical code, health effect - impact code, medical device problem code).

• Brand Name: UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE)
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 10814930
• MDR Text Key: 215479841
• Report Number: 3005975929-2020-00419
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 03596010502605
• UDI-Public: 03596010502605
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2013
• Device Catalogue Number: 74120158
• Device Lot Number: 090275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Sex: Male