MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 LNR MPACTOR HD II 28MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71366428
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during inspection, two (2) r3 lnr mpactor hd ii 28mm were found to be broken.As this was noticed upon field inspection, there was no patient involvement.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: additional information received by the manufacturer identified that this event should be re-evaluated for mdr reporting.The new information received confirmed that there is nothing broken on or off the r3 lnr mpactor hd ii 28mm.It did confirm multiple scratches, burrs and deep gouges in the device.The reassessment determined that the issue does not meet the threshold for reporting and therefore, it is a non-reportable event.If further details are provided, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: R3 LNR MPACTOR HD II 28MM
• 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: 15591369
• Report Number: 1020279-2022-04400
• Device Sequence Number: 2277695
• Product Code: JDG
• UDI-Device Identifier: 03596010656056
• UDI-Public: 03596010656056
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2022

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: 71366428
• Device Catalogue Number: 71366428
• Device Lot Number: 10KSY0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 10/24/2022; 11/01/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 10/31/2022; 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2010
• 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