MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

Catalog Number UNK_REC

Device Problems Break (1069); Loose or Intermittent Connection (1371); Unstable (1667); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 01/27/2014

Event Type  Injury  

Event Description

Doctor informed to product mangater that in revision operation of hmrs rotating hinge, originally operated 2005, all parts related to hinge construction were exchanged due to instability and hyperextension of knee (bushings and bumper were found to be broken and severely worn).The bumper 0°, 6483-2-150 with lot lcl298 was found to be exceptionally loose after locking it in place, meaning it didn't lock in place as it should be.The bumper was left in place because this was the only piece available in this revision operation.If this bumper won¿t stay in place because of poor locking this will end up in rerevision.

Manufacturer Narrative

Catalog number is unknown at this time.The device was reported as an unknown 2 bushings.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available, the evaluation summary will be submitted in a supplemental report.Not returned to manufacturer.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3638825
• MDR Text Key: 4286535
• Report Number: 0002249697-2014-00471
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2014
• 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): Required Intervention