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

Catalog Number	74122154
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a bhr revision surgery performed on (b)(6) 2019, the patient presented redness of the distal portion of the wound as well as tenderness to palpation, due to localized cellulitis.Antibiotic prescribed to her pharmacy.On (b)(6) 2019.This adverse event was treated with prescribed antibiotics.Current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6.It was reported that, after a bhr revision surgery, the patient presented redness of the distal portion of the wound as well as tenderness to palpation.As of today, the devices, all of which were used in treatment, remain implanted and therefore cannot be tested.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 insert and the cup, 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, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.Cellulitis is a known complication of any surgery and is associated with the procedure and not associated with a mal performance of the implant.The patient was treated with oral antibiotics and noted be improving.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.The root cause can be traced to an adverse event related to the surgical procedure, in which the device had no influence.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
Additional information: d10 (concomitant products added).

• 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: 17438777
• Report Number: 3005975929-2023-00105
• Device Sequence Number: 2598233
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2024

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 Expiration Date: 07/30/2014
• Device Catalogue Number: 74122154
• Device Lot Number: 09GW24334
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/10/2023; 08/20/2024
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 08/17/2023; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2009
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-2014-12.
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDICATIONS: CYCLOBENZAPRINE, ESCITALOPRAM OXALA; PN: 71306611 / LN: 18LM10377; PN: 71342800 / LN: 18KM15815; PN: 74121648 / LN: A1718624
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 104 KG