MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 40 S/+0; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75100869
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner tab of the trial femoral head 40 s/+0 was broken.As noticed during field inspection, there was not patient involvement.
Additional Manufacturer Narrative
It was reported that the inner tab of the trial femoral head 40 s/+0 was broken.As noticed during field inspection, there was not patient involvement.The product, which intent use is in treatment, was not returned for investigation and no batch number was communicated.The reported failure can therefore not be evaluated.No batch record review could be performed.A complaint history review reveals several complaints which reported a similar failure of the device.Nevertheless the available information for this case is insufficient to fully investigate the reported issue.No statement can be given whether the specifications were met.Furthermore no contributing factors can be named.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.Based on the available information a thorough investigation cannot be conducted and the root cause of the reported issue remains undetermined.A relationship between reported event and device can not be confirmed.No further actions have been initiated.If the reported device or additional information become available, this investigation will be reopened.

• Brand Name: TRIAL FEMORAL HEAD 40 S/+0
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11808875
• Report Number: 9613369-2021-00202
• Device Sequence Number: 19810556
• Product Code: LZO
• UDI-Device Identifier: 07611996122022
• UDI-Public: 07611996122022
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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: 75100869
• Device Catalogue Number: 75100869
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1