MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122154
Medical Device Problem Codes	Biocompatibility (2886); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Local Reaction (2035); Muscle/Tendon Damage (4532); Insufficient Information (4580)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Event or Problem Description
It was reported that, after a bhr system had been implanted on an unspecified date, the plaintiff experienced an unspecified adverse event that was addressed via revision surgery on (b)(6) 2023.No additional information was provided.
Event or Problem Description
It was reported that, after a right bhr resurfacing procedure was performed on the (b)(6) 2016, the patient presented severe pain and x-rays showed a malposition of the acetabular component and an mri showed significant inflammatory soft tissue destruction involving the iliotibial band, gluteus minimus and half of the gluteus medius.The patient underwent a revision surgery on the (b)(6) 2023 and received a tha system in exchange.The patient tolerated the procedure well.
Additional Manufacturer Narrative
B5, d1, d2a, d2b, d4, d6a, g4, h6.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to an unspecified adverse event.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, a complaint history review, manufacturing record review, or definite escalation actions review could not be performed.A review of the product¿s instructions for use was not possible due to limited information about the details of the event and device.Without basic part details or an alleged failure mode, no risk file review is possible.No further actions are required at this time.If more information is received, this investigation will be reopened.The requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the unspecified complications.With the limited information provided, the patient impact beyond the reported revision cannot be determined.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.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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.
Additional Manufacturer Narrative
H3, h6.It was reported that a right hip revision surgery was performed due to severe pain, malposition of the acetabular component and significant inflammatory soft tissue destruction.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 devices concerned 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 the cu and the head, and this failure will continue to be monitored.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the head.As no device batch number was provided for investigation, manufacturing record review could not be performed for the head.If more information is received, this investigation will be reopened.In the absence of the actual devices, the production records were reviewed for the cup 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 products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.Per the surgical technique, the acetabular component is to be impacted with 15-20 degrees of anteversion and 40-45 degree inclination angle.However, the acetabular component was indicated to be in approximately 3 degrees of anteversion.It is unknown if this position of the acetabular component was a migration since implantation and if it led to accelerated wear resulting in the reported pain and weakness as well as the inflammatory soft tissue destruction involving the gluteus muscle.It cannot be concluded that the reported clinical symptoms are related to a malperformance of the implant or implant failure.The impact to the patient beyond the revision surgery cannot be determined.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.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.H11.Corrected information in h6 (health effect - clinical code and medical device problem code).

• Brand Name: ACETABULAR CUP HAP SIZE 48/54
• 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: 16928312
• Report Number: 3005975929-2023-00069
• Device Sequence Number: 20563203
• Product Code: NXT
• UDI-Device Identifier: 03596010552297
• UDI-Public: 03596010552297
• Combination Product (Y/N): N
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/21/2023

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: 74122154
• Device Catalogue Number: 74122154
• Device Lot Number: 14JW15346A
• 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: 04/23/2023
• Supplement Date Received by Manufacturer: 06/07/2023; 06/07/2023; 07/21/2023
• Initial Report FDA Received Date: 05/14/2023
• Supplement Report FDA Received Date: 06/12/2023; 06/28/2023; 07/21/2023
• 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: PN: 74123148 / LOT: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male