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

Catalog Number	71420844
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	03/23/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that status post right total knee arthroplasty, patient was re-admitted to the hospital due to uncontrolled pain and possible acute infection.Patient had baseline right thigh pain radiating from his back, but reports that pain had gotten a bit worse after surgery.Patient received an mri.Tolerating po.Pain was controlled with morphine sr.Patient was febrile (99.6) had a swollen and painful knee.He was admitted for febrile workup, observation and possible washout.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and 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¿.This patient has now had left hip total hip arthroplasty.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.

• Brand Name: GII PS INSERT SZ 7-8 9MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8167845
• Report Number: 1020279-2018-02798
• Device Sequence Number: 215261
• 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
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 12/04/2021
• Device Catalogue Number: 71420844
• Device Lot Number: 11MM04405
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/16/2018
• Supplement Report FDA Received Date: 03/21/2019
• 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; Other
• Patient Age: 56 YR