MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR CURVED CUP INTRODUCER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	90128257
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr surgery the tip of one (1) bhr curved cup introducer broke.The procedure was performed, without any delay, using a sn back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H11: after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that the tip of one (1) bhr curved cup introducer broke.However, after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable, since a visual inspection of the returned device finds the strike plate weld fractured, the component is used external to the patient where it is not possible for pieces to fall into the surgical site/incision.Moreover, if the device malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury.H3, h6: the alleged instrument was returned for evaluation.Based on the device evaluation, the device returned heavily worn from use, with the strike plate weld fractured and the strike plate returned off the device.A review of the historical complaints data for the alleged devices 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 cup introducer.This failure will continue to be monitored via routine trending.The subject instrument has been in distribution for more than 10+ years, likely experiencing multiple uses and worn or damaged from repeated normal use, misuse, and cleaning practices.Surgical instruments are subject to normal wear and tear throughout their life and over time may no longer perform as intended.Therefore, a device history records review for this incident is considered unnecessary as no other evidence to suggest a manufacturing deficiency in this case, thus this is unlikely to be identified as a cause or contributing factor.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 root cause can likely be ascribed to component failure.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.Furthermore, the damage found in the visual inspection indicates that the device will not function as intended.Therefore, all reusable instruments must be routinely inspected for signs of wear and damage after reprocessing.Any instruments found to be damaged should be replaced as necessary to ensure their proper functioning and to maintain patient safety.This guidance is provided by the bhr surgical technique.Based on this investigation, the need for corrective and preventative actions is not indicated.The instrument will be discarded.

• Brand Name: BHR CURVED CUP INTRODUCER
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22804819
• Report Number: 3005975929-2025-00081
• Device Sequence Number: 15413204
• Product Code: NXT
• UDI-Device Identifier: 03596010533791
• UDI-Public: 03596010533791
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 90128257
• Device Lot Number: S0710152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown