MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20DEG 36MM TRIAL 52MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71367952
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a thr surgery, the locking tab of an r3 20deg 36mm trial 52mm broke.It is unknown how the procedure was completed; however, a non-significant delay occurred as a consequence of this issue.No other complications were reported.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the reporter mistakenly reported this device since it did not fail, the correct faulty device was already reported under your reference number (b)(4) (our internal complaint reference number: (b)(4) ), therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Internal complaint reference number: (b)(4) additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the reporter mistakenly reported this device since it did not fail, the correct faulty device was already reported under your reference number (b)(4) (our internal complaint reference number: (b)(4) ), therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Internal complaint reference number: (b)(4).

• Brand Name: R3 20DEG 36MM TRIAL 52MM
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13725421
• Report Number: 1020279-2022-01124
• Device Sequence Number: 14608272
• Product Code: JDG
• UDI-Device Identifier: 03596010599872
• UDI-Public: 03596010599872
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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: 71367952
• Device Catalogue Number: 71367952
• 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: 02/21/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 04/08/2022
• 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
• Patient Sex: Unknown