MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)

Patient Problems Injury (2348); Non-union Bone Fracture (2369)

Event Date 01/02/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

Its alleged by the attorney, through the filing of a lawsuit, that on or about (b)(6) 2016 the plaintiff underwent an open reduction internal fixation to repair her broken femur.Its further alleged that an incorrect plate was used and implanted in her femur.Plaintiff underwent revision surgery on (b)(6) 2018 to remove the incorrect hardware as well as a corrective osteotomy and repair of the nonunion.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation no other evidences were provided.More detailed information about the complaint event as well as the affected device, patient¿s medical records and x-rays (intraoperative & postoperative) must be available in order to determine the root cause of the complaint event.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.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 Description

Its alleged by the attorney, through the filing of a lawsuit, that on or about on (b)(6) 2016 the plaintiff underwent an open reduction internal fixation to repair her broken femur.Its further alleged that an incorrect plate was used and implanted in her femur.Plaintiff underwent revision surgery on (b)(6) 2018 to remove the incorrect hardware as well as a corrective osteotomy and repair of the nonunion.

• Brand Name: UNKNOWN PLATE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9488906
• MDR Text Key: 185608747
• Report Number: 0008031020-2019-02287
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 01/27/2020
• Supplement Dates FDA Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention