MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH BASEPLATE IMPACTOR EXTRACTOR; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-4-805

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Rep reported patient had primary surgery for a total right knee.There was an issue with the inserter not releasing from the implant.Secondary device used in its place that happen to be available.Only a few minutes delay with no impact to patient.As per sales rep phone call on 10/14/2016: the primary implant is still attached to the inserter so a second implant and back up inserter needed to be used to complete the surgery.

Manufacturer Narrative

An event regarding seizing involving a baseplate impactor extractor was reported.The event was confirmed.Method & results: device evaluation and results: the device was returned in used condition.There are scratches on the ¿lock¿ side of the device.The device is found to be non-functional as it cannot be disassembled from the baseplate.The locking lever is stuck.Medical records received and evaluation: not performed as medical records were not provided for review.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: visual inspection confirmed the reported event.The impactor extractor cannot be released from the implant as the locking lever is stuck.

Event Description

Rep reported patient had primary surgery for a total right knee.There was an issue with the inserter not releasing from the implant.Secondary device used in its place that happen to be available.Only a few minutes delay with no impact to patient.As per sales rep phone call on (b)(6) 2016: the primary implant is still attached to the inserter so a second implant and back up inserter needed to be used to complete the surgery.

• Brand Name: BASEPLATE IMPACTOR EXTRACTOR
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6087091
• MDR Text Key: 59804182
• Report Number: 0002249697-2016-03488
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-4-805
• Device Lot Number: SS146650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR