MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 29MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421029
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed, 2-4 weeks post operative, patient was in rehab and when reaching for walker to get up off toilet heard a cracking sound.Her distal femur broke above the femoral component, patient was hospitalized, the implants were removed and antibiotic spacer blocks were implanted due to infection.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, based on the engineering evaluation and the reported use of an inappropriately fitting cutting block, the root cause was human error.The evaluation determined the segmentation and smoothing errors could have caused the described fit, subsequent anterior slope of the distal femoral cut, and resultant notching described in the complaint, which required bony grafting during a 0-30 minute surgical extension (b)(6).Surgeon discretion/sound surgical judgment should be used with any instrumentation/component during the total knee procedure.It is unknown if the infection was revealed during the revision or if it was also a contributing factor to the periprosthetic fracture (b)(6).The patient impact beyond the reported femoral notching, minor surgical extension, periprosthetic fracture, probable pain and hospitalization course for revision and infection cannot be determined.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Product was sterilized according to sterilization release documentation from quality control.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GII OVAL RESURFACING PAT 29MM
• 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: 8661508
• Report Number: 1020279-2019-02137
• Device Sequence Number: 16665776
• Product Code: JWH
• UDI-Device Identifier: 03596010485052
• UDI-Public: 03596010485052
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: Health Professional
• Device Catalogue Number: 71421029
• Device Lot Number: 18KM21447
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 06/02/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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