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

Catalog Number UNK_REC

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 07/14/2015

Event Type  Injury  

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown size 5, thickness 11, x3 poly insert.When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

Locking wire was found disengaged from poly in the joint space.

Manufacturer Narrative

An event regarding dissociated locking wire involving a triathlon insert was reported.The event was confirmed.Method & results: device evaluation and results: the device was returned with the locking wire dissociated from the insert.The event was confirmed as the biological matter observed on the distal surface of the insert indicated the device became unseated and therefore unlocked from the baseplate.Medical records received and evaluation: no medical records were received.Device history review: there were no reported discrepancies for the lot.Complaint history review: there have been no other similar events for the lot.Conclusions: the event was confirmed per visual inspection of the explanted device.The root cause of the event could not be determined because additional information such as x-rays, operative reports, and patient history is needed.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available, this investigation will be reopened.

Event Description

Locking wire was found disengaged from poly in the joint space.

• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4999955
• MDR Text Key: 22845285
• Report Number: 0002249697-2015-02614
• Device Sequence Number: 1
• Product Code: JDI
• 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,other
• Reporter Occupation: Physician
• Report Date: 07/14/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 61 YR
• Patient Weight: 68