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

Catalog Number	74122158
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference:(b)(4).
Event or Problem Description
It was reported that, during a bhr surgery, the introducer wire of an acetabular cup hap size 52/58 snapped during impaction.The procedure was performed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that, during a bhr surgery, the introducer wire of an bhr acetabular cup snapped during impaction.The procedure was performed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.The device, for use in treatment, has not been returned for evaluation.A review of the historical complaints data for the devices concerned was performed.No other complaints were identified involving this batch.No similar complaints have been received in the past 12 months for the bhr cup.In the absence of the returned device, the inspection procedure for the applicable batch of cup wire reels was reviewed.All product was verified to meet the required standards, with no issues noted.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.Any identified risks are reduced in severity, occurrence and detection as far as possible.A review of prior escalation actions and the the device labelling confirmed that the following statement was added to the bhr surgical technique in 2010: "cautionary statement do not over tighten the acetabular component on the introducer.Over tightening and excessive wire tension may cause wire breakage." no further escalation actions are required based on this complaint.It should be noted as per the surgical technique that when attaching the cup using the wires and cup introducer, tension should be applied until the cup is securely attached to the introducer assembly.Care should be taken with over tightening and excessive wire tension as this may lead to wire breakage.After investigation, the potential root cause is user error, it cannot be concluded that the functional complications were associated with a mal-performance of the implant.No preventative or corrective action has been initiated as a result of this investigation.

• 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: 17435513
• Report Number: 3005975929-2023-00104
• Device Sequence Number: 15681933
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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: 74122158
• Device Lot Number: 22KW01986
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• 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
• Patient Sex: Unknown