MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 32 S/+0; PROSTHESIS,HIP,SEMICONSTRAIND,METALCRAMICPOLYMER,CMNTDORNONPOROUS,UNCEMENTED

Model Number	75100850
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set-up/inspection of a total hip replacement case, a trial femoral head 32 s/+0 was noticed to be very worn.Upon visual inspection, the device was noticed to be fractured.Surgery was performed, without any delay, with a smith & nephew back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: it was reported that, during set-up of a total hip replacement case, a trial femoral head 32 s/+0 was noticed to be very worn.The device, used in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could be confirmed.One flap is broken and was not returned.Apart from that, the device shows heavy signs of use such as gouges, cracks and scratches over the whole surface.These signs could origin from a forceps or similar.Due to the scratches, the batch number is not readable on the device.Nevertheless, a complaint history review was performed on the product number.There is no indication that the reported issue is related to a production issue and the occurrence calculated from the complaint data is in agreement with the corresponding risk files.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.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.According to the document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.Based on the conducted investigation, the reported failure mode and a relationship between the reported event and the device was confirmed.Smith+nephew will continue to monitor for similar issues.The returned device will be archived.

• Brand Name: TRIAL FEMORAL HEAD 32 S/+0
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAIND,METALCRAMICPOLYMER,CMNTDORNONPOROUS,UNCEMENTED
• 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: 14292014
• Report Number: 9613369-2022-00256
• Device Sequence Number: 1519650
• Product Code: LZO
• UDI-Device Identifier: 07611996121834
• UDI-Public: 07611996121834
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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 Model Number: 75100850
• Device Catalogue Number: 75100850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown