MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 7X26MM IMPL STEM W/SCR; EXTREMITY IMPLANT

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 01/06/2023

Event Type  Injury  

Event Description

It was reported that after examination of radiographs, it is indicated that the head is loose.A revision is planned, and the surgeon will attempt to restore the head with a new screw.No revision procedure has been reported to date.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).Report source: netherlands.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was further reported that the revision has taken place approximately a month ago.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

(b)(4).Proposed code: mechanical (g04)- stem.D10 - medical product: catalog #: 11-210023, explor 12x20mm implant head, lot # 212710.Reported event was unable to be confirmed due to limited information received from the customer.The single, undated xray provided that is reported to be after the initial post- op surgery at which the date is unknown.Hcp review of the xray would not enhance the investigation.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00544.

Event Description

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

• Brand Name: EXPLOR 7X26MM IMPL STEM W/SCR
• Type of Device: EXTREMITY IMPLANT
• 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: 16158401
• MDR Text Key: 307293726
• Report Number: 0001825034-2023-00081
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00880304210455
• UDI-Public: (01)00880304210455(17)310329(10)275050
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• 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: 11-210062
• Device Lot Number: 275050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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