MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TIB BASE SZ 2 RM/LL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	00584200202
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tka during surgery, was noticed that the tibial baseplate size 2 rt medial/lt lateral was damaged.A backup device was not available so it was required to pickup a second set of implants from a nearby hospital.A delay greater than 30 minutes occurred due to this event.No injuries to patient were reported.Additional details are not available at this moment.
Additional Manufacturer Narrative
Additional information: b1/b2/b5/g3/h1/h2/h6.
Event or Problem Description
It was reported that tka during surgery, the tibial baseplate size 2 rt medial/lt lateral completely broke inside the patient and dust was coming out.A backup device was not available so it was required to pickup a second set of implants from a nearby hospital.A delay greater than 30 minutes occurred due to this event.No injuries to patient were reported.Additional details are not available at this moment.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms although several additional attempts for complaint/response clarification were made, the contraindicating information in the complaint/responses has yet to be clarified as of the date of this assessment.It appears that the complaint was against an impactor; however, this has not been confirmed.The root cause could not be concluded based on the information provided.The patient impact beyond the greater-than-30-minute surgical delay could not be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/information and/or product evaluation findings become available, the clinical/medical task may be re-evaluated.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: TIB BASE SZ 2 RM/LL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11431784
• Report Number: 1020279-2021-01899
• Device Sequence Number: 3818224
• Product Code: HSX
• UDI-Device Identifier: 00885556619742
• UDI-Public: 00885556619742
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2021

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: 00584200202
• Device Catalogue Number: 00584200202
• Device Lot Number: 64615514
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/04/2021; 05/24/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/22/2021; 05/25/2021
• 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: Other; Required Intervention