MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TM ANKLE TIBIAL INSERT; ANKLE PROSTHESIS

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988)

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

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi # n/a.Barbara h currier, paul j hecht, james a.Nunley ii, michael b mayor, john h currier, douglas w.Van citters (2018).Ankle arthroplasty: what retrievals can tell us.American orthopaedic foot & ankle society.Https://doi.Org/10.1177/1071100718802589.Reported event was unable to be confirmed due to limited information received from the customer.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.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 filed for this event, please see associated reports: 0001822565 - 2018 - 06301, 0001822565 - 2018 - 06300.Not returned to manufacturer.

Event Description

It has been reported in the research article that, one patient had an ankle arthroplasty.Subsequently patient was revised approximately 0.8 years post initial surgery due to malposition.Burnishing was noted on the retrieved poly.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported in the research article that, one patient had an ankle arthroplasty.Subsequently patient was revised approximately 0.8 years post initial surgery due to malposition.Pain, deformity and failure of the fibular fixation/syndesmotic repair, with subsidence of the tibial component were further reported.Burnishing was also noted on the retrieved poly.Attempts have been made and no further information has been provided.

• Brand Name: UNKNOWN TM ANKLE TIBIAL INSERT
• Type of Device: ANKLE PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8054697
• MDR Text Key: 126644758
• Report Number: 0001822565-2018-06303
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00450001300,TALAR COMPONENT, 62478596; 00450004300, TIBIAL COMPONENT, 6251081; UNKNOWN TALAR COMPONENT; UNKNOWN TIBIAL COMPONENT; UNKNOWN TALAR COMPONENT; UNKNOWN TIBIAL COMPONENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR