MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420830
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during tka procedure the gii ps insert sz 5-6 9mm could not be fixed during primary surgery.This happened during use inside the patient.It was replaced by an identical backup insert.The back up could be inserted without further problems.A delay of less than 30 min was reported.No injuries reported at this time.
Event or Problem Description
It was reported that during tka procedure the gii ps insert sz 5-6 9mm could not be fixed during primary surgery.This happened during use inside the patient.It was replaced by an identical backup insert.The back up could be inserted without further problems.A delay of less than 30 min was reported.No injuries reported at this time.Device was discarded and is not available for evaluation.
Additional Manufacturer Narrative
Results of investigation: it was reported that during a tka procedure the genesis ii ps insert size 5-6 9mm could not be fixed during procedure.It was replaced by an identical sn backup inlay and was placed without problems.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts 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.A relationship, if any, between the device and the reported incident could not be corroborated.Some potential causes of the reported event could include but not limited to procedural/user variance, surgical technique used or size of device.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.We consider this investigation closed.
Additional Manufacturer Narrative
Sections d and e updated.

• Brand Name: GII PS INSERT SZ 5-6 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10738184
• Report Number: 1020279-2020-05776
• Device Sequence Number: 3061234
• Product Code: JWH
• UDI-Device Identifier: 03596010209641
• UDI-Public: 03596010209641
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2020

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: 71420830
• Device Catalogue Number: 71420830
• Device Lot Number: H2006068
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 10/26/2020; 10/30/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 10/27/2020; 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1