MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE STANDARD TAPER ADAPTOR; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mfr#0001825034-2018-01781.Concomitant products: comp rvs cntrl 6.5x30mm st/rst pn115396 ln765410; e1 44-36 std hmrl brng pnep-115393 ln211910; comp rvs tray co 44mm pn115370 ln641920; comp rvrs shldr glnsp std 36mm pn115310 ln341180.(b)(5).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was implanted into the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

During a shoulder revision procedure, the taper adaptor would not seat in the central screw hole over the screw.A shorter screw was tried in its place, but the issue persisted.The central screw was then removed and the taper adaptor fit.No medical intervention or patient impact was reported.No further information was available.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Root cause remains undetermined.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.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Medical product: comprehensive reverse central screw catalog#: 115396 lot#: 765410.E1 standard humeral bearing catalog#: ep-115393 lot#: 211910.Comprehensive reverse tray catalog#: 115370 lot#: 641920.Comprehensive reverse glenosphere 36mm catalog#: 115310 lot#: 341180.Comprehensive convertible glenoid baseplate, catalog#: pm0000797 lot#: 419480.Reported event was unable to be confirmed due to limited information received from the customer.Dhr 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 as the necessary information to adequately investigate the reported event was not provided.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

During a shoulder revision procedure, the taper adaptor would not seat in the central screw hole over the screw.A shorter screw was tried in its place, but the issue persisted.The central screw was then removed and the taper adaptor seated.The device was left implanted without a central screw.No further information is available.

• Brand Name: COMPREHENSIVE STANDARD TAPER ADAPTOR
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7352070
• MDR Text Key: 102888142
• Report Number: 0001825034-2018-01780
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• 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: 118001
• Device Lot Number: 298810
• Other Device ID Number: (01) 0 0880304 21724 9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention