MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN OSS DIAPHYSEAL SEGMENT; PROSTHESIS KNEE

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products - unknown oss tibial tray catalog # unknown lot # unknown, unknown oss bearing catalog # unknown lot # unknown, unknown oss auguments catalog # unknown lot # unknown, unknown oss femoral catalog # unknown lot # unknown, unknown oss stems catalog # unknown lot # unknown.(b)(4).Customer has indicated that the product will not be returned because product location is unknown.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.X-ray review indicates there is a radiodense structure seen slightly protruding in the posterosuperior hoffa's fat pad region could represent backing out of the distal locking screw, however, this cannot be confirmed based on the single image provided.  if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filled for this event: 0001825034-2017-09505.

Event Description

It was reported the patient underwent an orthopedic salvage procedure.Subsequently, the patient underwent a revision procedure approximately seventeen years post-implantation due to loosening of the last fixation screw through the femoral block of the distal femoral resection prosthesis.The surgeon was concerned that the loose screw was causing blockage of the knee joint and could possibly damage the metal prosthetic surface and articular surface.

• Brand Name: UNKNOWN OSS DIAPHYSEAL SEGMENT
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7314751
• MDR Text Key: 101563951
• Report Number: 0001825034-2018-01596
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 56