MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BOWED RADIAL SEGMENT 9930; PROSTHESIS, EXTREMITIES

Model Number N/A

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

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog# 32855910557 tm hex augment distal radius lot# 95006587; catalog# 32855910559 tm cyl aug proximal radius lot# 95006586; catalog# 00855910556 tm aug wire dist lot# 95006589; catalog# 00855910558 tm aug reseal dist lot# ni; catalog# 00855910563 tm aug wire prox lot# 95006588; catalog# 00855910564 tm aug reseal prox lot# ni; catalog# 00855910474 tm test plug lot# 95006590.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to location of device 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: 0001822565-2019-02111, 0001822565-2019-02115.

Event Description

It was reported that the patient underwent initial procedure on an unknown date.Subsequently the patient is being considered for a revision surgery due to loosening of the device.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

No device was returned.The complaint cannot be confirmed with the information made available.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.Root cause is unknown.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: BOWED RADIAL SEGMENT 9930
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8625820
• MDR Text Key: 145603060
• Report Number: 0001822565-2019-02113
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• 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: 32855910555
• Device Lot Number: 95006591
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2019
• 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
• Patient Age: 13 YR
• Patient Weight: 59