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

Model Number N/A

Device Problems Detachment Of Device Component (1104); Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Concomitant medical products: comprehensive shoulder mini taper adapter pn118000 ln432450.Comprehensive reverse baseplate pn010000589 ln327630.Humeral bearing pnxl-115364 ln247360.Comprehensive reverse glenosphere pn115310 ln529130.Comprehensive reverse tray pn115370 ln282550.Comprehensive primary stem pn113634 ln579830.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial total shoulder arthroplasty.Three months following, the surgeon performed a revision on this shoulder due to the glenosphere becoming disassociated from the baseplate for a second time.It was stated that the central screw was not seated the whole way.

Manufacturer Narrative

This follow-up report is being submitted to report additional information.

Manufacturer Narrative

This follow up report is being submitted to report additional information concomitant products - 010000589 name: comp rvrs 25mm bsplt ha+adptr lot: 327630; 115396 name: comp rvs cntrl 6.5x30mm st/rst lot: 064100; xl-115364 name: arcom xl 44-36 std +3 hmrl brg lot: 247360; 115310 name: comp rvrs shldr glnsp std 36mm lot: 529130; 115370 name: comp rvs tray co 44mm lot: 282550; 113634 name: comp primary stem 14mm mini lot: 579830; 180553 name: comp lk scr 3.5hex 4.75x30 st lot: 641780; 180552 name: comp lk scr 3.5hex 4.75x25 st lot: 409850; 180551 name: comp lk scr 3.5hex 4.75x20 st lot: 319610; 405880 name: comp rev fixed drl gd lot: unk.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Review of complaint history determined that no further action is required.Root cause was determined to be improper insertion of the central screw during the initial procedure.The screw bent during the initial procedure due to hard cortical bone, but was not discovered until the second revision.A summary of the investigation has been sent to the complainant.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: COMPREHENSIVE REVERSE SHOULDER 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: 7154820
• MDR Text Key: 96051887
• Report Number: 0001825034-2017-11510
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK132239
• 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,Followup,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 115396
• Device Lot Number: 064100
• Other Device ID Number: (01) 0 0880304 67708 1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2017
• 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
• Patient Age: 62 YR