MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TALAR COMPONENT SIZE 4 RIGHT ORANGE FOR USE WITH SIZE 4 TIBIAL COMPONENTS ONLY; PROSTHESIS, ANKLE

Model Number N/A

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 06/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: 00830004400, tm ankle tibial base size, 62890541.00830005400, prolong tibial insert sz 4 +0, 62777177.Customer has indicated that the product will not be returned to zimmer biomet for investigation, remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event; please see associated reports: 0001822565-2019-01558, 0001822565-2019-01561.

Event Description

It was reported that the patient under went and initial shoulder arthroplasty and subsequently experienced lateral and medial surgical wound dehiscence and infection.Antibiotic therapy, washing and medication were prescribed.No additional information is available from the event.

Event Description

No additional information is available to report.

Manufacturer Narrative

The complaint cannot be confirmed as no medical records were provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.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

It was reported that the patient underwent an initial ankle arthroplasty and subsequently experienced lateral and medial surgical wound dehiscence and infection.Antibiotic therapy, washing and medication were prescribed.No additional information is available from the event.

Manufacturer Narrative

The following report is being submitted to relay corrected information.The investigation is in process.Once the investigation has been completed, a follow up mdr will be submitted.

• Brand Name: TALAR COMPONENT SIZE 4 RIGHT ORANGE FOR USE WITH SIZE 4 TIBIAL COMPONENTS ONLY
• Type of Device: PROSTHESIS, ANKLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8562661
• MDR Text Key: 143677463
• Report Number: 0001822565-2019-01560
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00830002400
• Device Lot Number: 62912532
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 04/30/2019; 05/24/2019
• Supplement Dates FDA Received: 04/30/2019; 05/30/2019
• 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