MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BEARING; PROSTHESIS, HIP

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 07/09/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source switzerland.Customer has indicated that the product twill not be returned to zimmer biomet for the investigation as the product location is unknown.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: 0001825034 - 2022 - 01762.

Event Description

It was reported that a patient underwent a hip revision after an unknown amount of time post implantation due to the ceramic head coming off the poly bearing and luxation of the hip joint.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, the bearing was determined to not have caused or contributed to the event.The initial report was forwarded in error and should be voided.Reported event was unable to be confirmed due to limited information received from the customer.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: records were not provided for the initial right hip arthroplasty performed on an unknown date.Subsequently, the patient fell during the middle of the night about 3 weeks after the initial surgery and dislocated the hip.A closed reduction could not be performed, so an open reduction was performed to remove the liner and head and place new zimmer products.No complications were noted.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.It was noted the dislocation occurred due to a fall.As the reason for the fall is unknown, a definitive root cause cannot 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

Upon reassessment of the reported event, the bearing was determined to not have caused or contributed to the event.The initial report was forwarded in error and should be voided.

• Brand Name: UNKNOWN BEARING
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; .; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15140102
• MDR Text Key: 296992059
• Report Number: 0001825034-2022-01761
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/20/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 08/02/2022; 08/02/2022; 09/15/2022
• Supplement Dates FDA Received: 08/03/2022; 08/09/2022; 09/26/2022
• 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: UNK HEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female