MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TALAR COMPONENT ORANGE SIZE 4 RIGHT; PROSTHESIS, ANKLE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4) concomitant medical products - therapy date unknown.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.Complaint history review was unable to be performed, as the part number and lot number are unknown.Root cause is attributed to the patient's allergy to cobalt chrome.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.Device remains implanted.

Event Description

It was reported that patient underwent a right ankle procedure on an unknown date and subsequently is experiencing pain 3 years post-implantation.Allergy testing determined patient is allergic to cobalt chrome.Patient relayed that the surgeon wanted to fuse the ankle; however, the patient has declined this treatment.No further information is available, as the patient does not desire any additional contact.

Manufacturer Narrative

The following report is being submitted to relay additional information received 00450004400 tm total ankle tibia sz4 77003681 00450005400 prolong tibial insert sz 4 +0 62208575 00110100200 osteobond copolymer bone cement single kit 40gm 62664455 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional information is available to report at this time.

Event Description

No additional information is available to report at this time.

Manufacturer Narrative

The complaint is confirmed based on the medical reports.Review of device history records found these units were released to distribution with no deviations or anomalies.The root cause was identified as the patient condition.A summary of the investigation has been sent to the complainant.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.

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional information is available to report at this time.

Event Description

Complaint was reopened on (b)(6) 2019 as the patient requested a final response.Final response sent on (b)(6) 2019.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of the blood test results identified the following: titanium alloy particles - 2.7 mild reaction, nickel 0.1 mm - 6.3 reactive, vanadium 0.01 mm - 3.3 reactive.A summary of the investigation has been sent to the complainant.

• Brand Name: TALAR COMPONENT ORANGE SIZE 4 RIGHT
• Type of Device: PROSTHESIS, ANKLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7215803
• MDR Text Key: 98127431
• Report Number: 0001822565-2018-00528
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K120906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00450002400
• Device Lot Number: 62397421N
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN PART/LOT, TIBIA COMPONENT; UNKNOWN PART/LOT, TIBIA COMPONENT
• Patient Outcome(s): Other
• Patient Weight: 68