MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); No Information (3190)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: 2014.Concomitant medical products: therapy date: unknown, unknown femoral component, unknown bearing.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent initial knee arthroplasty.Subsequently, the patient experienced a fracture of the tibial plate.No revision has been reported to date.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Concomitant medical products: 00584201601 - femoral component ¿ 62750215, 00584202608 - articular surface - unknown.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by radiographs.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: interval tibial plate fracture and possible polyethylene wear.There is the somewhat lateral position of the tibial plate with respect to the femoral component which may have contributed to the tibial plate fracture.Device history record review was unable to be performed as the part and 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.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.

Event Description

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

Manufacturer Narrative

No product was returned; visual and dimensional evaluations could not be performed.However, fracture of the tibial implant was confirmed via x-ray analysis.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: interval tibial plate fracture and possible polyethylene wear.There is a somewhat lateral position of the tibial plate with respect to the femoral component which may have contributed to the tibial plate fracture.No other medical records were provided.The likely condition of the part when it left zimmer biomet control is considered conforming based on the potential in-vivo age (4.5 years) of the device.A definitive root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent initial knee arthroplasty.Subsequently, the patient was revised due to a fractured tibial plate.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the tibial component was fractured into 3 pieces.The device also exhibited signs of being implanted.Fracture analysis of the returned device identified the fracture surfaces on two of the fragments show significant post-fracture damage.Marks indicative of fatigue and final overload fracture were noted on the fragments.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the records from the revision surgery identified the patient presented with pain and the tibial component was fractured.Medical records from the initial surgery were not provided.The updated information does not change the previous investigations conclusions.Per the unicompartmental knee package insert, pain and fracture are known potential adverse effects of this procedure.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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

This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TIBIAL COMPONENT PRECOAT LEFT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8631260
• MDR Text Key: 145747079
• Report Number: 0001822565-2019-02126
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• 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: 00584200601
• Device Lot Number: 62781339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other