MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI-DBLE LEAD CORT 5.0X75MM SCR; ROD,FIXATION/TRAUMA

Model Number N/A

Device Problems Unstable (1667); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446); Ambulation Difficulties (2544)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial right ankle arthroplasty.Approximately five (5) months after initial surgery the patient underwent a revision surgery due to a non-healing wound and the product was removed.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.A definitive root cause could not be determined.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.

Event Description

It was reported that the patient underwent a revision procedure approximately two (2) months after the initial procedure due to a non-healing wound.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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

The reported event of deep infection >90 days occurred post implantation.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.After investigation/reassessment, the item was determined to be not reportable.The initial report and additional supplemental reports should be voided.

Manufacturer Narrative

(b)(4).The reported event of deep infection >90 days occurred post implantation.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.After investigation/reassessment, the item was determined to be not reportable.The initial report and additional supplemental reports should be voided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.It cannot be confirmed at this time which of the following devices were involved in the reported event.Applicable product id is one of the following: d4 - item number: 14-405075; d4 - lot number: 304810; d4 - expiration date: 11/15/2028; h4 - manufacture date: 11/15/2018.  or the part/lot information could be:   d4 - item number: 14-405028; d4 - lot number: 324950; d4 - expiration date: 9/8/2028; h4 - manufacture date: 9/8/2018.Or the part/lot information could be:   d4 - item number: 14-405034; d4 - lot number: 571220; d4 - expiration date: 10/17/2028; h4 - manufacture date: 10/17/2018.D10: medical products: item#: 14-440218, ankle locking nail 11 x 180mm; lot#: 440470.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: TI-DBLE LEAD CORT 5.0X75MM SCR
• Type of Device: ROD,FIXATION/TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11877169
• MDR Text Key: 252434872
• Report Number: 0001825034-2021-01585
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K063570
• 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: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• 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: UNKNOWN NAIL
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 134