MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74123152
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after an unspecified metal on metal hip construct had been implanted on the patient¿s right hip on (b)(6) 2016.The patient sustained an unspecified injury and required a revision surgery on (b)(6) 2021.The identity of the explanted devices and the prosthesis implanted in exchange is unknown.The patient¿s outcome is unknown.
Additional Manufacturer Narrative
H3, h6.It was reported that the patient sustained an unspecified injury and required a revision surgery on (b)(6) 2021.The patient¿s outcome is unknown and the devices, used in treatment, were not returned for analysis.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.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 are required.A risk management review was performed for the acetabular cup.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.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint from a clinical perspective.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate the details supplied in 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.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.
Event or Problem Description
It was reported that, after a bhr acetabular cup and head had been implanted on the patient¿s right hip on (b)(6) 2016, the patient started to get grinding sensation, audible noise, and instability sensations in the right hip, and is limping.The patient required a revision surgery on (b)(6) 2021.The acetabular head and cup were explanted and competitor stryker implants were used.It is noted that the patient seven (7) weeks post-revision is doing well.
Additional Manufacturer Narrative
B7: other relevant history, including preexisting medical conditions.B5: describe event or problem, d1: brand name, d4: catalog #, unique identifier (udi) #, g5: pma/510(k) # h6: health effect - clinical code, health effect - impact code and medical device problem code.
Additional Manufacturer Narrative
H3, h6: it was reported that, after a bhr acetabular cup and head had been implanted, the patient started to get grinding sensation, audible noise, and instability sensations in the right hip, and is limping.The patient required a revision surgery.The acetabular head and cup were explanted and competitor implants were used.It is noted that the patient seven (7) weeks post-revision is doing well.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 alleged devices.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 have been identified for the cup and head, and this failure will continue to be monitored.As no device batch numbers were provided for investigation, manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The review of the most recent 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, no prior applicable escalation actions were identified.No further escalation actions are required.The available medical documents were reviewed.A clinical root cause could not be determined.The elevated metal ions, moderate darkened/blackened synovitis, and instability sensations are consistent with metal debris.The loosened acetabular component can lead to metal debris; however, the clinical root cause of the loosening cannot be confirmed, the reported ¿unspecified injury¿ cannot be ruled out as a potential factor.The patient impact is determined to be the reported revision.It¿s noted 7-wks.Status post revision right total hip arthroplasty; he is doing well.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.

• Brand Name: BHR RESURFACING FEMORAL HEAD 52MM
• Common Device Name: 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14599400
• Report Number: 3005975929-2022-00383
• Device Sequence Number: 6085644
• Product Code: NXT
• UDI-Device Identifier: 03596010552433
• UDI-Public: 03596010552433
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/17/2024

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 Catalogue Number: 74123152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 07/13/2022; 06/21/2024; 07/12/2024
• Initial Report FDA Received Date: 06/04/2022
• Supplement Report FDA Received Date: 07/13/2022; 07/11/2024; 07/17/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETABULAR CUP HAP SIZE 52/58
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 55 YR
• Patient Sex: Male