MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL/COMP TI STD TAPER; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem Erosion (1750)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: catalog #: 115326, comp rvrs shldr glnsp +6 41mm, lot # 213380, catalog #: 115330, comp rvrs shdr glen bsplt +ha, lot # 524140, catalog #: unknown, comprehensive 41 mm humeral tray standard, lot # unknown, catalog #: unknown, comprehensive stem 11 mm cemented; lot # unknown, catalog #: unknown, comprehensive humeral bearing; lot # unknown, 115330 comp rvrs shdr glen bsplt +ha 524140, 115383 comp rvs cntrl scr 6.5x35mm st 345360, 180505 comp locking screw 4.75x40mm 468620, 180502 comp locking screw 4.75x25mm 015250, 180502 comp locking screw 4.75x25mm 633670, 180506 comp locking screw 4.75x45mm 029390.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Reported event was considered confirmed as the medical records and x-rays note scapular notching.Device history record was reviewed and no discrepancies relevant to the reported event were found.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04333 and 0001825034-2020-00440.Remains implanted.

Event Description

It was reported that the patient had initial right total shoulder arthroplasty performed approximately nine (9) years ago.Subsequently, the patient was revised about a year ago due to humeral tray fracture from a traumatic event with secondary pain and dislocation.The patient continued physical therapy and home exercises post-revision with satisfactory progress and pain management.Incidentally, scapular notching was noted on the six (6) month post-revision x-rays.No intervention planned at this time.

• Brand Name: VERSA-DIAL/COMP TI STD TAPER
• 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: 9660988
• MDR Text Key: 177541188
• Report Number: 0001825034-2020-00439
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304217249
• UDI-Public: (01)00880304217249
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080642
• 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: 01/29/2020

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: 118001
• Device Lot Number: 001810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• 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): Other