MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 4.5 MM L-BUTTRESS PLATE ANGLED RIGHT 4 HOLES 85 MM LENGTH; TRAMA IMPLANT

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Necrosis (1971); Osteopenia/ Osteoporosis (2651)

Event Date 06/22/2020

Event Type  Injury  

Event Description

It was reported that there was device loosening and migration of the device six months postoperative.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 47494500411, 4.5 mm l-buttress plate angled left 4 holes, lot #: unknown.Catalog #: unknown, unknown screws, lot #: unknown, qty.(b)(4).Report source: france.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.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: 0001822565-2022-02741, 0001822565-2022-02745, 0001822565-2022-02746, 0001822565-2022-02747, 0001822565-2022-02748, 0001822565-2022-02749, 0001822565-2022-02750, 0001822565-2022-02751, 0001822565-2022-02752.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Event Description

It was reported that there was necrosis, poor bone quality, and migration of the device six months postoperative of a right tibia fracture repaired with plate and screws.No additional patient consequences were reported.

Event Description

Upon receipt of additional information, it has been determined that the device did not cause or contribute to the reported event.The device did not loosen, but osteonecrosis contributed to migration with a few bone parts.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that the device did not cause or contribute to the reported event.The event occurred due to patient's bone quality.The initial report was forwarded in error and should be voided.

• Brand Name: 4.5 MM L-BUTTRESS PLATE ANGLED RIGHT 4 HOLES 85 MM LENGTH
• Type of Device: TRAMA IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15459626
• MDR Text Key: 300298917
• Report Number: 0001822565-2022-02743
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• 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: 47494500412
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention