MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS II POSTERIOR STABILIZED INSERT SIZE 3-4 11MM; PAT-FEM-TIB, SEMI-CSTRND, CMNTD, POLY/METAL/POLY

Model Number	71420818
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during the tka procedure, the gii ps insert sz 3-4 11 mm could not be inserted.It was then tried to insert another gii ps insert sz 3-4 11 mm, but it was not possible either.A third implant was used.It is unknown if surgery was delayed.No patient injury or other complications were reported at the moment.
Additional Manufacturer Narrative
Updated b5: description of problem.
Event or Problem Description
It was reported that, during the tka procedure, the gii ps insert sz 3-4 11mm could not be inserted.It was then tried to insert another gii ps insert sz 3-4 11mm, but it was not possible either.A third implant from smith & nephew was used.The procedure had a delay of 15 min.No patient injury or other complications were reported.
Additional Manufacturer Narrative
It was reported that, during the tka procedure, the gii ps insert sz 3-4 11mm could not be inserted.It was then tried to insert another gii ps insert sz 3-4 11mm, but it was not possible either.A third implant from smith and nephew was used.The procedure had a delay of 15 min.No patient injury or other complications were reported.The affected complaint device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device found deformation on the locking detail and around the edges.Deep scratches are observed on the surface.A dimensional evaluation was not performed as the damage/deformation at several features of the device would not allow for accurate measurement.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.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.Some potential causes could include but are not limited to limited to surgical technique or user/procedural variance.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GENESIS II POSTERIOR STABILIZED INSERT SIZE 3-4 11MM
• Common Device Name: PAT-FEM-TIB, SEMI-CSTRND, CMNTD, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10934457
• Report Number: 1020279-2020-06911
• Device Sequence Number: 871286
• Product Code: JWH
• UDI-Device Identifier: 03596010209580
• UDI-Public: 03596010209580
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2021

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: 71420818
• Device Catalogue Number: 71420818
• Device Lot Number: J2010651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 11/10/2020; 06/07/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/17/2020; 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1