MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SPINDLE; PROSTHESIS KNEE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Insufficient Information (4580)

Event Date 10/27/2022

Event Type  Injury  

Event Description

It was reported patient was revised due to unknown reasons.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.

Manufacturer Narrative

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

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

Event Description

It was reported patient was revised due to bone fracture 9 months post implantation.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

D6a: (b)(6) 2022 d10 - medical product: unknown anchor plug catalog # unknown lot # unknown.Multiple mdr reports were filled for this event: 0001825034-2023-02799.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.Medical records review indicates there is loosening and mild varus alignment of the proximal humeral implant as noted but this belongs to linked complaints.No implant or bone fracture was noted from the x-ray.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.

• Brand Name: UNKNOWN SPINDLE
• Type of Device: PROSTHESIS KNEE
• 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 ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17388148
• MDR Text Key: 319663048
• Report Number: 0001825034-2023-01716
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2023

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 08/01/2023; 11/13/2023
• Supplement Dates FDA Received: 08/29/2023; 11/29/2023
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female