MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. GII PS INSERT SZ 7-8 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420844
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/30/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient (b)(6) was diagnosed with right knee instability after his primary total knee arthroplasty on 2012.A revision surgery was performed and the articular insert was removed and exchanged for a larger insert.Also, it was determined that would be benefit a patella implant insertion since the patient's patella indicated wear.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Our clinical/medical team concluded based on the available information, the root cause for ¿uncontrolled pain and possible acute infection¿ or the later ¿pain and stiffness¿ that resulted in the resurfacing and larger size insert cannot be concluded.However, it is not an uncommon occurrence if the patella was not resurfaced during the primary surgery.Nor can the root cause of the ¿aseptic loosening¿ that resulted in the revision of the tibial base plate and polyethylene liner with an ¿irrigation and debridement¿ be concluded as aseptic loosening can have several causes.At a (b)(6) 2017 ¿ follow-up comparison of x-rays to (b)(6) 2016 ¿ ¿no visible periprosthetic fracture of significant lucency¿.Without the return of the actual product involved, our investigation cannot proceed.A definitive root cause cannot be determined with the information provided.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII PS INSERT SZ 7-8 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7927186
• Report Number: 1020279-2018-02011
• Device Sequence Number: 11241276
• Product Code: JWH
• UDI-Device Identifier: 03596010209719
• UDI-Public: 03596010209719
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: No Information
• Device Expiration Date: 12/04/2021
• Device Catalogue Number: 71420844
• Device Lot Number: 11MM04405
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 01/23/2019
• 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: 58 YR