MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE TS AXSOS FOR RIGHT FEMUR 12 HOLE / L274MM; PLATE, FIXATION, BONE

Catalog Number	437532
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	11/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was reported through an attorney, as a result of a legal claim.Due to the ongoing litigation no additional information is available at this time.If additional information is received it will be reported on a supplemental report.Device is not available.
Event or Problem Description
Its reported by the attorney, through the filing of a lawsuit, that the plaintiff underwent a left total knee replacement on (b)(6) 2016, that required revision on (b)(6) 2017, due to a non-union femoral shaft fracture.
Additional Manufacturer Narrative
The reported event that distal lateral femur plate ts axsos for right femur 12 hole / l274mm was alleged of issue s-90 (additional/revision procedure) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.The batch record could not be reviewed because the affected device was not returned and the lot number was not communicated.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.As conveyed in ifu, non-union is the most frequent adverse effects involving the use of internal fracture which may be clinically related rather than device related.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Its reported by the attorney, through the filing of a lawsuit, that the plaintiff underwent a left total knee replacement on (b)(6) 2016 that required revision on (b)(6) 2017 due to a nonunion femoral shaft fracture.

• Brand Name: DISTAL LATERAL FEMUR PLATE TS AXSOS FOR RIGHT FEMUR 12 HOLE / L274MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8250121
• Report Number: 0008031020-2019-00027
• Device Sequence Number: 2189700
• Product Code: HRS
• UDI-Device Identifier: 07613154396252
• UDI-Public: 07613154396252
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K061012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: Lay User/Patient
• Device Catalogue Number: 437532
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 03/26/2019
• 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: Required Intervention