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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mfr#0001825034-2018-02315, mfr#0001825034-2018-02320, mfr#0001825034-2018-02324, mfr#0001825034-2018-02325, mfr#0001825034-2018-02326.Concomitant products: comprehensive reverse shoulder humeral bearing pnxl-115363 ln788490; comprehensive reverse shoulder humeral tray pn115370 ln638620; comprehensive reverse shoulder primary mini length stem pn113634 ln169240; comprehensive reverse shoulder glenosphere baseplate pn115330 ln364670; comprehensive reverse shoulder versa-dial standard adaptor pn118001 ln940930; 115381 name: comp rvs cntrl scr 6.5x25mm st lot: 843160; 180500 name: comp locking screw 4.75x15mm lot: 618000; 180504 name: comp locking screw 4.75x35mm lot: 045540; 180504 name: comp locking screw 4.75x35mm lot: 990190; 180500 name: comp locking screw 4.75x15mm lot: 276230; 405889 name: comp rvs 2.7mm dia drl lot: 740070; 405800 name: comp.Rev shldr 9 in steinmann lot: 850910.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is 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 initial shoulder procedure.Subsequently, the patient was revised due to unknown reasons six years later.The patient's total shoulder was explanted and a spacer was implanted.No further information is available.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE
• 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: 7396841
• MDR Text Key: 104367007
• Report Number: 0001825034-2018-02322
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 115310
• Device Lot Number: 785040
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2012
• 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: 64 YR