MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 LNR MPACTOR HD II 38-42MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71366438
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference: (b)(4).
Event or Problem Description
It was reported that a r3 lnr impactor hd ii 38-42 mm cracked vertically while impacting a liner.This occurred during thr procedure, instrument inside the patient.No harm or injury reported on patient.Procedure was finished with a smith and nephew back up device.There was a less than 30 minutes delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment was returned for evaluation.A visual inspection confirmed the r3 lnr mpactor hd ii 38-42mm is cracked.The device shows significant signs of wear/usage.A medical investigation was conducted and confirms per complaint details, an r3 lnr impactor hd ii 38-42mm cracked vertically while impacting a liner; however, a s+n backup was used to complete the procedure without harm or injury reported on patient.Reportedly, there was a delay of less than 30 minutes.Based on the photo which confirms the reported crack, no material appears to be missing.Responses to the requested clinical documentation/information had not been received as of the date of this investigation, therefore, the root cause and the patient impact beyond the reported modified procedure and 0-30 minute surgical delay could not be determined; however, no patient injury was reported.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 LNR MPACTOR HD II 38-42MM
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11088917
• Report Number: 1020279-2020-07913
• Device Sequence Number: 2666911
• Product Code: JDG
• UDI-Device Identifier: 03596010656087
• UDI-Public: 03596010656087
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71366438
• Device Catalogue Number: 71366438
• Device Lot Number: 10KSY0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention