MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 S/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100856
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a thr surgery, a piece of a trial femoral head 36 s/+0 broke off, it was retrieved from the patient's wound by the operating surgeon.Surgery was performed, without any delay, with the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Results of investigation: it was reported that, during a thr surgery, a piece of a trial femoral head 36 s/+0 broke off, it was retrieved from the patient's wound by the operating surgeon.Surgery was performed, without any delay, with the same device.Patient was not harmed as consequence of this problem.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.However, a provided picture confirms the reported failure mode.As batch number was not communicated, a review of the production documentation could not be performed.A complaint history review was performed.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Since no patient harm is being reported no further clinical/medical assessment is warranted at this time.The relationship between the reported event and the device can be confirmed.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.The root cause of the reported issue remains undetermined.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag", all devices must be inspected and controlled for proper functioning after cleaning/disinfection.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might break off.These issues are due to high loads, beyond the design limit, that may arise on the tabs during manipulation.The failure modes may further be exacerbated by excessive use of the device over time.The performance of the device is within the risks level that are anticipated in the risk management documentation.The current design remains therefore state of the art.As part of the continuous improvement smith + nephew is nonetheless working on a design enhancement, options are currently being reviewed and tested at our facility.The current design will be further monitored through post-market surveillance processes.No further actions are necessary at this time point.

• Brand Name: TRIAL FEMORAL HEAD 36 S/+0
• Common Device Name: 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: 13515313
• Report Number: 9613369-2022-00029
• Device Sequence Number: 14549188
• Product Code: LZO
• UDI-Device Identifier: 07611996121896
• UDI-Public: 07611996121896
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2022

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 Model Number: 75100856
• Device Catalogue Number: 75100856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 03/21/2022; 11/29/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 04/06/2022; 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown