MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 35MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY

Catalog Number	71421035
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Neck Stiffness (2434)
Date of Event	04/15/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a manipulation under anesthesia and injection of periarticular pain cocktail was performed to a patient due to right knee stiffness, status post total knee arthroplasty revision.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and although it was reported that an mua was preformed no procedure documentation was provided for review.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported instability cannot be determined however, during the revision it was found that the polyethylene was dissociated from the base plate, and this is likely a contributing factor to the instability.The patient impact beyond the revision itself cannot be concluded.Information around the patient¿s post operative rehabilitation prior to this mua was not provided.No further medical assessment is possible at this time based on the information provided.A review of complaint history on the listed part revealed no prior complaints for the listed batch 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.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by (b)(6).A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information, surgical procedure/post-operative care review, and device labeling (including technique guides, ifus, etc.).

• Brand Name: GII OVAL RESURFACING PAT 35MM
• 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: 8156106
• Report Number: 1020279-2018-02767
• Device Sequence Number: 244087
• Product Code: JWH
• UDI-Device Identifier: 03596010485076
• UDI-Public: 03596010485076
• 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): 06/09/2019

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: 11/15/2021
• Device Catalogue Number: 71421035
• Device Lot Number: 11LM10830
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 06/09/2019
• 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: 52 YR