MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE CENTRAL SCREW; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/05/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mfr#0001825034-2018-02249.Concomitant medical products: comp primary stem 15mm std pn113655 ln340650, comp rvrs shdr glen bsplt +ha pn115330 ln364680, comp rvs tray +5mm co 44mm pn115375 ln299770, comp rvsr shldr glnsp +3 36mm pn115313 ln940850, versa-dial/comp ti std taper pn118001 ln883850, e1 44-36 std hmrl brng pnep-115393 ln081300, comp locking screw 4.75x15mm pn180500 ln478530, comp locking screw 4.75x15mm pn180500 ln674840, comp non-lckng screw 4.75x25mm pn180509 ln195950, comp non-lckng screw 4.75x25mm pn180509 ln436560.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial right reverse total shoulder arthroplasty.Subsequently, the patient was revised due to screw fracture 17 months later.The central screw and lower screw had to be removed using a broken screw extractor.Metallic debris was removed from the site; a couple of small metallic fragments were retained.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record was reviewed and no discrepancies were found.Review of complaint history determined no further action(s) is/are required.Root cause was unable to 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 that the patient underwent an initial right reverse total shoulder arthroplasty.Subsequently, the patient was revised due to screw fracture 17 months later.The central screw and lower screw had to be removed using a broken screw extractor.Drill bits also fractured while trying to remove the screw fragment, creating metal debris.Metallic debris was removed from the site; however, a couple of small metallic fragments were retained.

• Brand Name: COMPREHENSIVE REVERSE CENTRAL SCREW
• Type of Device: PROSTHESIS, SHOULDER
• 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: 7413275
• MDR Text Key: 104915146
• Report Number: 0001825034-2018-02248
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 115386
• Device Lot Number: 447930
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2009
• 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
• Patient Age: 65 YR