MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 LNR MPACTOR HD II 32MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71366432
Medical Device Problem Code	Break (1069)
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, one (1) r3 lnr mpactor hd ii 32mm was found broken.As this was noticed upon field inspection, no patient was involved.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, two (2) r3 lnr mpactor hd ii 32mm were found broken.As this was noticed upon field inspection, no patient was involved.
Additional Manufacturer Narrative
Additional information: b5, d4, d9, h4.
Additional Manufacturer Narrative
H3, h6: the associated devices were returned and evaluated.A visual inspection of the returned devices did not confirm the stated failure.There is nothing broken on or off the devices.The visual did confirm multiple scratches, burrs and deep gouges in the devices.These devices show signs of significant wear and use.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.The contribution of the device to the reported event could not be corroborated.These devices are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 LNR MPACTOR HD II 32MM
• 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: 15592130
• Report Number: 1020279-2022-04410
• Device Sequence Number: 2136096
• Product Code: JDG
• UDI-Device Identifier: 03596010656063
• UDI-Public: 03596010656063
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2022

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: 71366432
• Device Catalogue Number: 71366432
• Device Lot Number: 11DSY0023
• 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; 11/10/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 10/28/2022; 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2011
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown