MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI LOW PROFILE SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Failure of Implant (1924); Pain (1994); Dizziness (2194); Ambulation Difficulties (2544); Balance Problems (4401); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ref (b)(4) lot 705240 ringloc shell 54mm, ref xl-105924 lot 403680 arcom liner, ref (b)(4) lot 596070 mallory stem size 9, ref (b)(4) lot 343920 modular head 32mm-3.Foreign: country: (b)(6).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03487, 0001825034-2021-03488, 0001825034-2021-03489, 0001825034-2021-03490.

Event Description

It was reported the patient underwent an initial right total hip arthroplasty.The patient alleges that he experienced pain, loss of balance, dizziness and difficulty in walking and upset stomach due to the deterioration and failure of implant.Patient also alleges elevated ion levels.No revision has been reported at this time.No additional information.

Event Description

Upon reassessment of the reported event, the screw was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, the screw was determined to be not reportable as it is not believed to have contributed to the event.The initial report was forwarded in error and should be voided.

• Brand Name: TI LOW PROFILE SCREW
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13098308
• MDR Text Key: 283407949
• Report Number: 0001825034-2021-03491
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K082446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• 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: 103534
• Device Lot Number: 175850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other
• Patient Sex: Male