MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN REDAPT ACET CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 09/30/2023

Event Type  Injury  

Event Description

It was reported that, after a hip replacement had been conducted on an unspecified date with a redapt acetabular system, the patient experienced an undisclosed adverse event that led to a revision surgery on (b)(6) 2022.The 58 mm redapt modular cementless acetabular component was retained, while other unspecified implants were replaced with zimmer biomet implants.One year later, the patient has experienced an infection.The patient has consulted several professionals: primary doctor, dermatologist, surgeon, infection specialist, vascular surgeon.Problems related to these areas were discarded.It is unknown how this adverse event was treated and the current health status of the patient is not provided.

Manufacturer Narrative

H10: internal complaint reference: case-(b)(4).

Manufacturer Narrative

Given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that a procedural variance versus user error cannot be ruled out as the likely cause of the reported adverse event that led to the revision surgery.The instructions for use documents for total hip system does warn: ¿do not mix components from different manufacturers unless specially approved by the manufacturer of the components.Failure to comply may result in implant failure and revision surgery.¿ with the limited information provided, a definitive root cause of the reported infection could not be confirmed or concluded, nor could it be established that this event is related to the malperformance of the s+n implant or an implant failure.The patient impact beyond the reported undisclosed adverse event, the revision and the subsequent infection cannot be determined.Since it is unknown how the infection was treated and the current health status of the patient is unknown further impact to the patient cannot be determined.Therefore, no further clinical/medical assessment can be rendered at this time.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file, prior actions and sterilization records review could not be performed.However, a review of the instructions for use documents for total hip systems revealed that infection, both early, post-operative superficial and early, post-operative deep wound infection and late periprosthetic infection could occur.This has been identified as a potential complication associated with total hip arthroplasty surgery, primary or revision.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include procedural variance, user error, injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKNOWN REDAPT ACET CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18397446
• MDR Text Key: 331372842
• Report Number: 1020279-2023-02608
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• 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): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female