MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TUBEPLT 2H SUPER WING 135DX4H; PLATE, FIXATION

Catalog Number 48121913504

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 03/03/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item number 48-1201-095-00 tiv lag screw 95mm long lot # 62975571.Item number 48-2319-036-00 tiv self tap screw 36mm lot # 64223549.Item number 48-2319-036-00 tiv self tap screw 36mm lot # 64223549.Item number 48-2319-040-00 tiv self tap screw 40mm lot # 63980015.Item number 48-2319-042-00 tiv self tap screw 42mm lot # 63762256.Item number 48-1200-001-00 ti-compression screw lot # 64149850.Report source: foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that initial ti-versa surgery was performed.Subsequently, the patient was revised due to pain and loosening of the lag screw.The surgeon also found some black matter at the time of revision around the implant which was removed from the patient body.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

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

• Brand Name: TUBEPLT 2H SUPER WING 135DX4H
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11657099
• MDR Text Key: 245154974
• Report Number: 0001822565-2021-00992
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024105805
• UDI-Public: (01)00889024105805(17)200131(10)62847587
• 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
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 48121913504
• Device Lot Number: 62847587
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention