MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK POLY; PROSTHESIS, EXTREMITIES

Catalog Number UNK POLY

Device Problems Mechanical Problem (1384); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Pain (1994); Tissue Damage (2104); Osteopenia/ Osteoporosis (2651); No Information (3190)

Event Date 07/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.If any further information 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

It was reported that a patient underwent a ankle procedure on an unknown date, subsequently, the patient is being considered for a revision on an unknown day to swap out poly for an unknown reason.The sales rep was inquiring about implant identification.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Unable to perform a compatibility check.Medical records were provided and reviewed by a health care professional.Review of the available records identified patient have anteromedial pain above the ankle joint and increased uptake corresponding with pseudoarthrosis (lack of fusion) of the distal tib/fib joint and bony debris in the anteromedial gutter.A dexa scan revealed osteopenia and osteoporosis as well.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.If any further information 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.The investigation is still in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information 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

It was reported that a patient underwent an ankle procedure approximately 3 years ago.Subsequently, the patient is scheduled to be revised to for bone excision and poly exchange.Revision was initially scheduled for this month, but was postponed approximately 1 month amid the cancellation of non-essential cases for covid-19 concerns.Reason for revision is due to bony impingement in anteromedial and anterolateral ankle gutters.No other zb products being revised.Medical records reviewed: ct / bone scan / xray results reveal increased uptake corresponding with pseudoarthrosis (lack of fusion) of the distal tib/fib joint and bony debris in the anteromedial gutter.

• Brand Name: UNK POLY
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9853607
• MDR Text Key: 189445971
• Report Number: 0001825034-2020-01188
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK POLY
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 100