MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 40 L/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 75100871

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(6).

Event Description

It was reported that, during thr surgery, the inner plastic locking pieces of one (1) trial femoral head 40 l/+8 fractured after removing from stem.No pieces fell into the patient.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H3, h6: it was reported that, during total hip replacement surgery, the inner plastic locking pieces of one (1) trial femoral head 40 l/+8 fractured after removing from stem.No pieces fell into the patient.Patient was not injured as consequence of this problem.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.No batch number was communicated so the production history review was not possible.Due to an unknown batch number, the review of historical complaints was performed on product number basis only, revealing 2 additional complaints over the past 12 months with similar failure mode.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The root cause of the event can be attributed to a known inherent risk of the device.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might bend or break off.These failure modes may further be exacerbated by excessive use of the device over time.The performance of the device is still within the risks level that are anticipated in the risk management documentation.The current design will be further monitored through post-market surveillance processes.No further actions are necessary at this time point.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: TRIAL FEMORAL HEAD 40 L/+8
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17782671
• MDR Text Key: 323855487
• Report Number: 9613369-2023-00191
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996122046
• UDI-Public: 07611996122046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132435
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75100871
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1