MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 29MM; PRSTHSS,KNEE,PTLLFMRTIBL,SMI-CNSTRND,CMNTD, POLYMER/METAL

Catalog Number	71421029
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was scheduled for a patient due to a fracture of the medial aspect of left proximal tibial metaphysis.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis was performed on the returned explant and some scratching and wear was seen on the inferior and superior surface of both the medial and lateral compartments of the tibia base, and the lock details on both inserts showed signs of material deformation.Based on the investigation conducted, root cause for this observed insert damage could not be determined.On the as-received tibia base plate, bone cement was observed to still be adhered to the fixation surface, and it was noted by the surgeon that the base plate was well-fixed to the bone when revision surgery was performed.Some scratches were present on the superior side of the base plate but no major damage was observed on this component.No material or manufacturing deviations were observed during this investigation.A clinical evaluation was conducted and based on the available information, the root cause of this periprosthetic fracture that required the revision is likely as stated the patient¿s underlying ¿osteopenia¿ and not related to the returned baseplate and the two uni components.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.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII OVAL RESURFACING PAT 29MM
• Common Device Name: PRSTHSS,KNEE,PTLLFMRTIBL,SMI-CNSTRND,CMNTD, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7869398
• Report Number: 1020279-2018-01794
• Device Sequence Number: 16731512
• Product Code: JWH
• UDI-Device Identifier: 03596010485052
• UDI-Public: 03596010485052
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

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 Catalogue Number: 71421029
• Device Lot Number: 18AM23134
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 02/14/2019
• 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; Required Intervention
• Patient Age: 71 YR