MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 7-8 9MM; PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMICONSTRAINED CEMENTED POLYMERMETALPOLYMER

Catalog Number	71420844
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision was performed on an insert and soft tissue was clean out.A thicker insert was implanted.
Additional Manufacturer Narrative
Pma/510k correct date added.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, based on the reported revision/upsizing of the poly insert and ¿soft-tissue clean-out¿ along with the lateral-sided pain, soft tissue impingement or irritation from hardware could have been contributing factors to the reported pain and subsequent revision, although, these are not apparent in the single image provided.Patient impact beyond the reported pain, revision procedure and an expected brief post-op rehab is not anticipated.No further medical assessment can be rendered at this time.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.

• Brand Name: GII PS INSERT SZ 7-8 9MM
• Common Device Name: PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMICONSTRAINED CEMENTED POLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8210570
• Report Number: 1020279-2019-00020
• Device Sequence Number: 1682716
• Product Code: JWH
• UDI-Device Identifier: 03596010209719
• UDI-Public: 03596010209719
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2019

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: 10/15/2011
• Device Catalogue Number: 71420844
• Device Lot Number: 01KM07322
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 11/28/2018; 11/28/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 03/01/2019; 04/24/2019
• 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