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	Malposition of Device (2616)
Health Effect - Clinical Codes	Hematoma (1884); Deformity/ Disfigurement (2360)
Date of Event	03/05/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after undergoing left hip bhr hip resurfacing surgery on (b)(6) 2014, the patient experienced malpositioning of the acetabular component.This adverse event was treated by performing a revision surgery on (b)(6) 2014.During this procedure, it was observed that the patient presented old hematoma blood, which was evacuated without the need of a drain.The original 58 mm bhr cup was replaced with a 60 mm bhr cup and the femoral head was retained.
Additional Manufacturer Narrative
H10: internal complaint reference: case (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that a left hip revision surgery was performed due to malpositioning of the acetabular component.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 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, no prior applicable escalation actions were identified.The available medical documents were reviewed.A hematoma is a known complication of any surgical procedure and is likely associated with the surgery.The intraoperative finding of the acetabular component being too vertical is consistent with the reported ¿malpositioning of the acetabular component¿.A variation in surgical technique cannot be ruled out as a contributing factor to the reported event.It cannot be concluded the too vertical acetabular or hematoma were associated with a mal performance of the implant or implant failure.The patient impact beyond the reported revision cannot be determined with the limited information provided.Based on the information provided, the root cause can be attributed to problems traced to the user not following the manufacturer's instructions, resulting in the device being implanted in a incorrect position.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: 16943005
• Report Number: 3005975929-2023-00084
• Device Sequence Number: 12491620
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2018
• Device Model Number: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 13LW18972
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2013
• 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: BHR RESURFACING FEMORAL HEAD 52MM, LOT#:13MW13751.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Male