MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X20MM ST/RST; SCREW, FIXATION, BONE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Erosion (1750)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

Procode: phx.(b)(4).Multiple mdr's were filed in association with this reporting: 0001825034 -2019 -05143, 0001825034 -2019 -05144, 0001825034 -2019 -05145, 0001825034 -2019 -05146, 0001825034 -2019 -05147.Concomitant medical products: taper adaptor 115310 lot:222460, non-locking screws 180558 lot:860890, non-locking screw 180557 lot 217280, fixed screw 180551 lot: 455490, fixed screw 180550 lot 494250, mini baseplate 010000589 lot:357320, ministem 113632 lot:300720 , humeral bearing xl115363 lot 503500, humeral tray 9707938-00 lot 17013429, glenosphere 115310 222460.Report source: event occured in the (b)(6).No product was returned.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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

It was reported the patient was revised to address glenoid implant related bone loss.Subsequent xrays show glenosphere baseplate has pulled away from bone.No further information is available at the time of this reporting.

• Brand Name: COMP RVS CNTRL 6.5X20MM ST/RST
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9376292
• MDR Text Key: 168027282
• Report Number: 0001825034-2019-05149
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00880304677067
• UDI-Public: (01)00880304677067
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2019

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
• Device Catalogue Number: 115394
• Device Lot Number: 572030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2017
• 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): Hospitalization; Required Intervention