MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122158
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Us legal it was reported that, after a right bhr resurfacing construct had been implanted on the patient¿s right hip on (b)(6) 2010 due to osteoarthritis, the patient experienced an infection.A two-stage revision surgery was performed to address this complication.First stage performed on (b)(6) 2022.During this procedure, the resurfacing head and cup were explanted.Intraoperatively, a gross purulence was identified upon opening the capsule.The wound was thoroughly debrided, and an antibiotic spacer was placed.The procedure went uneventful, and the patient was transfer to recovery room in stable condition.Second stage revision surgery date is unknown.
Additional Manufacturer Narrative
Internal reference: (b)(4).
Additional Manufacturer Narrative
H3, h6.It was reported that a two-stage revision surgery was performed to address an infection after a right bhr resurfacing construct was implanted.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 head, and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices 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.Although a joint infection and subsequent two-stage revision was reported, the clinical root cause of the infection cannot be confirmed; however, the reported infection is highly likely of an exogenous nature.It cannot be concluded the reported infection was associated with a mal performance of the implant or implant failure.The patient impact beyond the joint infection, and two-stage revision cannot be determined with the limited information provided.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.

• Brand Name: ACETABULAR CUP HAP SIZE 52/58
• 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: 16862760
• Report Number: 3005975929-2023-00058
• Device Sequence Number: 20282661
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• 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: 2010
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 10AW25647
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 74123152 / LOT: 10CW25932
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male