MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R ART INS SZ 7-8 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420510
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a revision surgery performed due to consistent pain.
Additional Manufacturer Narrative
The associated complaint devices were not returned.(b)(4): a clinical evaluation was conducted and the results from the arthrocentesis revealed a crp level of 10.00mg/l all other labs where within normal limits.There was no indication of any medical interventions provided to address the elevated crp.The x-rays provided taken years after the elevated crp provided had the suspicion of the loosening of the tibial or femoral components of right tka.Details regarding the patient¿s weight-bearing status, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported pain cannot be determined.However, the loosening of the components could have been a contributing factor to the reported the pain.Although a fluoroscopically guided right tka aspiration was performed two months post revision no result were provided for review.Therefore, were are unable to confirm an infection as a contributory factor.The patient impact beyond the reported pain cannot be determined.No further clinical assessment is warranted at this time.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.We consider this investigation closed.

• Brand Name: GII C/R ART INS SZ 7-8 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8348605
• Report Number: 1020279-2019-00654
• Device Sequence Number: 1833371
• Product Code: JWH
• UDI-Device Identifier: 03596010207999
• UDI-Public: 03596010207999
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2019

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: 02/04/2024
• Device Catalogue Number: 71420510
• Device Lot Number: 14BM03879
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 06/16/2019
• 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: 55 YR