MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN INSERT SIZE 10; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number UNK_JR

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

An event regarding size/fit issue involving an unknown insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned. clinician review: no medical records were received for review with a clinical consultant. device history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.  additional information including device details, return of the device, photographs/video of the event as it happened and operative reports are required to fully investigate the event and determine a root cause.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

During a tka case.Surgeon trailed a size 10 poly insert and put in the implant however the surgeon said that it didn't feel the same.The surgeon did the same procedure with a size 11 and did not like the implant and so he used a size 12 trail and liked the implant size.There is no additional information can be provided by the surgeon or hospital.No additional information will be available.

• Brand Name: UNKNOWN INSERT SIZE 10
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9307264
• MDR Text Key: 186800808
• Report Number: 0002249697-2019-03730
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other