MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 46X18X53 HUM HEAD; EXTREMITIES, IMPLANT

Model Number N/A

Device Problem Migration (4003)

Patient Problem Tissue Damage (2104)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# pm0000279; lot# 237880; comp pat mat cnv glen collins.Item# cp0000235; lot# 236700; compr cnv e1 brg.Foreign report source: (b)(6).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-04258.

Event Description

It was reported patient underwent a primary tsr.Subsequently, the patient developed a rotator cuff tear resulting in antero-superior migration of the humeral head resulting in the need for revision surgery to convert to reverse tsr.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.

Event Description

No additional information was reported.

Manufacturer Narrative

Visual examination of the provided pictures identified the explanted head and glenoid.No conclusions can be made regarding the product.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: on the ap view, the humerus is superiorly subluxed/dislocated with respect to the glenoid base plate.On the axillary view, the humerus is moderately anteriorly subluxed with respect to the glenoid base plate.No malalignment is corroborated on the transscapular y-view.The bones are intact.The hardware demonstrates no fracture.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.It was noted by the surgeon that "he does not believe the implants were the cause of the revision surgery.At the time of the primary surgery, the patient¿s rotator cuff was intact.Over time, the patient has developed rotator cuff arthropathy causing a antero-superior subluxation of the humeral head requiring revision surgery to convert to a reverse shoulder replacement," however this was unable to be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VERSA-DIAL 46X18X53 HUM HEAD
• Type of Device: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10938499
• MDR Text Key: 219310945
• Report Number: 0001825034-2020-04257
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304212220
• UDI-Public: (01)00880304212220
• Combination Product (y/n): N
• PMA/PMN Number: K060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• 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: 113042
• Device Lot Number: 599200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2021
• 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 Weight: 87