MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 M/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100857
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was noticed that, during the surgery, the head trial would become easily disassociated from the trial stem while trialing.Upon inspection following the surgery, it was noticed that the trial is fractured at the stem taper locking region.The procedure had been completed using the same device.A surgical delay of 30 min or less was reported.No injury to the patient was reported.
Additional Manufacturer Narrative
Results of investigation: it was reported that during surgery, the head trial became easily disassociated from the trial stem while trialing.Upon inspection following the surgery it was noticed that the trial is fractured at the stem taper locking region.The procedure was completed using the same device.A surgical delay of 30 min or less was reported.No injury to the patient was reported.The device, intended for use in treatment, was not returned for investigation and no batch number was communicated.The reported failure can therefore not be evaluated.Based on the available information a thorough investigation cannot be conducted and the root cause of the reported issue remains undetermined.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
H6: medical device problem code was added.Internal complaint reference: (b)(4).

• Brand Name: TRIAL FEMORAL HEAD 36 M/+4
• 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
• MDR Report Key: 11133868
• Report Number: 9613369-2021-00001
• Device Sequence Number: 11793739
• Product Code: LZO
• UDI-Device Identifier: 07611996121902
• UDI-Public: 07611996121902
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2021

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: 75100857
• Device Catalogue Number: 75100857
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 01/15/2021; 01/22/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 01/19/2021; 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1