MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TALAR COMPONENT; PROSTHESIS, ANKLE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Tissue Damage (2104)

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 00830004300, tibial base component size 3, lot # 63342717.Catalog #: 00830005300, tibial insert component size 3, lot # 63414807.Catalog #: 00493500903, one-third tubular plate with collar, lot # 63518815.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.The investigation is in process.Once the investigation has been completed, 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019 -03610, 0001822565-2019-03612, 0001822565-2019-03615.Device evaluated by manufacturer? remains implanted.

Event Description

It was reported that the patient underwent primary ankle approximately two years ago.Subsequently at the two year visit the patient was experiencing moderate pain, restricted rom, drainage, and was noted to have impingement.A month ago the patient underwent arthroscopic & debridement procedure, the implant remains implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Correction: a1.Reported event was confirmed by review of medical records/radiographs.Review of the available records identified the following: no complications reported from the initial procedure.Patient underwent arthroscopic & debridement procedure.Validated post debridement, no impingement.Device history record was reviewed and no discrepancies 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.

Event Description

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

• Brand Name: TALAR COMPONENT
• Type of Device: PROSTHESIS, ANKLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8954084
• MDR Text Key: 156260504
• Report Number: 0001822565-2019-03611
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2019
• 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: 00830002300
• Device Lot Number: 62946236
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2019
• 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 Weight: 64