MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 5-6 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POL/M/POL

Model Number	71420834
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka surgery, the genesis ii ps insert size 5-6 13mm could not be implanted.The procedure was finished with a change in surgical technique by using a different thickness insert: an 11mm was used instead of the 13mm one.It is unknown if there was a surgical delay.The patient was not harmed beyond the reported event.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).Results of investigation: it was reported that during a tka surgery, the genesis ii ps insert size 5-6 13mm could not be implanted.The procedure was finished with a change in surgical technique by using a different thickness insert, an 11mm was used instead of the 13mm one.The affected r3 complaint device, used in treatment, was returned and evaluated.A visual inspection of the returned device shows damage on the lock detail probably from the attempted insertion.Dimensional analysis could not be performed as the damage/deformation on the part 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.A relationship, if any, between the device and the reported incident could not be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.No medical documents were received for investigation.The patient impact beyond the reported 0-30 minute surgical extension and modified surgical procedure could not be determined.However, knee laxity could not be ruled out as a potential effect of choosing the less than optimal insert thickness.

• Brand Name: GII PS INSERT SZ 5-6 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POL/M/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10379640
• Report Number: 1020279-2020-03776
• Device Sequence Number: 3551314
• Product Code: JWH
• UDI-Device Identifier: 03596010209665
• UDI-Public: 03596010209665
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2020

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 Expiration Date: 11/21/2025
• Device Model Number: 71420834
• Device Catalogue Number: 71420834
• Device Lot Number: 15LM18527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 11/26/2020
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 70