MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 7-8 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	71421522
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to surgery for a poly swap.When the surgeon open the knee, he realised that the posterior side of the poly post was clearly damage.He could easily flex the post.He then removed the worn out poly, and replace it by a brand new one.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A lab analysis reveals the returned device was examined visually.No destructive analysis was performed.The returned component is pictured in.Damage/deformation was observed on the articular surface of the insert; these features have been reported as being created by third-body particulate (bone cement, bone, etc.) in the joint space.Cement and bone particulate are known to be produced during a total knee arthroplasty (tka), even under carefully controlled conditions.The non-articulating surface of the insert is also damaged and scratched.Both the articulating and non-articulating surfaces of the insert are discolored.Both the anterior and posterior surfaces of the post are deformed and damaged.The posterior surface of the post experienced more damage and deformation than the anterior surface.No material or manufacturing deviations were observed.A clinical evaluation was conducted and based on the available information, the root cause of the breakage and wear could have been damage from ¿third-body particulate¿ as suggested in the product analysis.No clinical/medical documents have been provided.It is unknown how much the rigorous physical stress of the patient¿s work and body habitus with a bmi=31.8 contributed to the issue and if the damage to the front of the post was from hyperextension and what the root cause was from the implantation date was not provided, however the age of the implant could also be a contributing factor in the ¿worn¿ condition of the insert.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GII PS HIGH FLEXION INSERT SZ 7-8 9MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7533710
• Report Number: 1020279-2018-00991
• Device Sequence Number: 233390
• Product Code: JWH
• UDI-Device Identifier: 03596010492975
• UDI-Public: 03596010492975
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2019

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 Expiration Date: 04/28/2015
• Device Catalogue Number: 71421522
• Device Lot Number: 05DM03390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 05/13/2018
• Supplement Date Received by Manufacturer: 05/13/2018; 10/31/2019
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 10/05/2018; 11/29/2019
• 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
• Patient Age: 65 YR
• Patient Weight: 122