MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 9X30MM IMPL STEM W/SCREW; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: radial head, 11-210043 with lot nr 611770.Report source: foreign- the event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by mfr: device remains implanted.

Event Description

It was reported the patient experienced pain post procedure.It was identified the screw backed out of the radial head.No further information has been provided at this time.It has not been indicated the patient has been revised.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of device history records found these units were released to distribution with no deviations or anomalies.No product was returned.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: "overall fit appears normal, although there is a dislodged screw.Alignment is normal.Bone quality appears normal.No signs of loosening, wear, radiolucency, or contributing factors are detected." the complaint is confirmed.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.

Event Description

No further information available at the time of this reporting.

• Brand Name: EXPLOR 9X30MM IMPL STEM W/SCREW
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8678783
• MDR Text Key: 147328078
• Report Number: 0001825034-2019-02275
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• 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: 11-210064
• Device Lot Number: 424080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention