MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DIAH SEG LOCK SCREW SET; PROSTHESIS KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products- unknown femoral component catalog#: ni lot#: ni, unknown tibial component catalog#: ni lot#: n.I.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.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.Unknown if product will be returned.

Event Description

It was reported that the patient had a revision due to a screw becoming loose and was stuck into the patella.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 153866, finn yoke long reinforced, lot # 526720, catalog #: 153984, finn mod tibial bearing std 14, lot # 599880.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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Reported event was considered as the returned device was fractured as well as the x-rays showing a metallic foreign body.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

• Brand Name: DIAH SEG LOCK SCREW SET
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8360328
• MDR Text Key: 136845896
• Report Number: 0001825034-2019-00732
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 150481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31 YR