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

Model Number N/A

Device Problems Corroded (1131); Migration or Expulsion of Device (1395); Material Twisted/Bent (2981); Naturally Worn (2988)

Patient Problems Tissue Damage (2104); Reaction (2414)

Event Date 12/17/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: crs humeral tray ¿ cat.No.115340, lot no.561910, crs glenosphere baseplate ¿ cat.No.115330, lot no.514450, crs central screw ¿ cat.No.115383, lot no.552680, fixed locking screw ¿ cat.No.180501, lot no.918900, fixed locking screw ¿ cat.No.180503, lot no.186950, fixed locking screw ¿ cat.No.180502, lot no.988280, fixed locking screw ¿ cat.No.180500, lot no.432960, fixed locking screw ¿ cat.No.180503, lot no.186960, crs humeral bearing ¿ cat.No.Xl-115363, lot no.176400, crs glenosphere ¿ cat.No.115316, lot no.803450, crs stem ¿ cat.No.113628, lot no.098490.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Product location unknown.

Event Description

It was reported that patient underwent right total reverse shoulder arthroplasty.Subsequently, patient underwent a revision procedure due to the dissociation of the glenosphere following a traumatic injury.During revision it was noted that there was extensive polyethylene damage from the dissociation.There was some burnishing on the morse taper in addition to a bending deformation and signs of metallosis.New implants were put inside the patient and the surgery was completed with no complications.No further information is available at this time.

Manufacturer Narrative

(b)(4).Review of the patient operative notes confirm the reported event.Review of device history records did not identify any related manufacturing deviations or anomalies that would have contributed to the reported event.Root cause is attributed to patient anatomy.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

No further information has been made available at the time of this reporting.

• Brand Name: VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7779329
• MDR Text Key: 116999485
• Report Number: 0001825034-2018-05105
• 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: other
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 303620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR