MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453174
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a genesis ii tkr the surgeon was unable to lock a size 3-4 12mm ps insert into a size 3 tibial baseplate.Implant was checked before opening and it was the correct implant.The surgeon ensured there was no blood/debris in the way and tried again.He was still not successful.There was not a second implant at the hospital and there was a delay while a new one was sent from the office.During the delay the surgeon trialled a 13mm insert and decided that was a good choice.The size 3-4 13mm locked into the size 3 tibia the first time with no problem.
Additional Manufacturer Narrative
It was reported that during a genesis ii tkr the surgeon was unable to lock a size 3-4 12mm ps insert into a size 3 tibial baseplate.There was not a second implant at the hospital and there was a delay while a new one was sent from the office.During the delay the surgeon trialled a 13mm insert and decided that was a good choice.The size 3-4 13mm locked into the size 3 tibia the first time with no problem.The affected complaint device, used in treatment, was returned and evaluated.A visual inspection of the returned device shows deformation on the part probably from attempted insertion.Dimensional analysis could not be performed as the severe damage/deformation at the lock detail 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.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.Some potential causes of the reported event could include but are not limited to size of device 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: LGN PS HIGH FLEX XLPE SZ 3-4 12MM
• 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: 10428236
• Report Number: 1020279-2020-04061
• Device Sequence Number: 1896378
• Product Code: JWH
• UDI-Device Identifier: 00885556486993
• UDI-Public: 00885556486993
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K071071
• 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
• Report Date (Section B): 11/05/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71453174
• Device Catalogue Number: 71453174
• Device Lot Number: 17FM02867
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 11/05/2020
• 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: Hospitalization; Required Intervention