MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JII UNI TIB XLPE INS SZ 1-2 8MM LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71935205
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during a surgery, the surgeon encountered difficulties in placing a uni-compartmental knee prosthesis insert from the journey uni 2 range.The insert was eventually damaged due to its difficult insertion, so the surgeon changed it to another identical insert (same batch and size).This second insert gave the same difficulties and the same result: it was impossible to insert it into the tibial base despite the surgeon once again implementing all the precautions (pulsed washing, drying and checking that there was no interposition by soft parts, cement or blood).As a result, the surgeon took a new insert, identical but from a different batch, which snapped into the tibial base quite normally.There were no immediate consequences for the patient, apart from an extension of a few minutes of the operating time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection confirms heavy damage to the locking detail due to attempting to insert of the device.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.A medical investigation was conducted and confirms this case reports that there were difficulties placing the uni insert, and it eventually became damaged.Per complaint details, a second insert of the same size was attempted, and also had difficulty seating.The surgery was completed using a third insert of the same size, but a different lot.There was a minimal procedural delay, however no patient harm was reported.Therefore, no further assessment is warranted at this time.A complaint history review found related failures; 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.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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: JII UNI TIB XLPE INS SZ 1-2 8MM LM/RL
• 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: 11391039
• Report Number: 1020279-2021-01665
• Device Sequence Number: 3256805
• Product Code: HSX
• UDI-Device Identifier: 00885556578841
• UDI-Public: 00885556578841
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K152315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: 71935205
• Device Catalogue Number: 71935205
• Device Lot Number: 19JAP0050A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 02/28/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1