MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 46X27X46 HUM HEAD; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 08/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: catalog #: 113633, comp primary stem 13mm mini m mini, lot # 180300; catalog #: pt-113950, pt hybrid glen post regenerex generex, lot # 724320; catalog #: 113954, md hybrid glenoid base 4mm d base 4mm, lot # 293790; catalog #: 118001, versa-dial/comp ti std taper pr adaptor, lot # 497590.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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: 0001825034-2020-01915, 0001825034-2020-01916, 0001825034-2020-01917, 0001825034-2020-01918.Product location unknown.

Event Description

It was reported that the patient had an initial left total shoulder arthroplasty approximately two (2) and half years ago.The patient was revised a year later to a reverse due to subscapularis failure.No further information available.

Manufacturer Narrative

Cmp-(b)(4).Updated: b4, b5, g4, h1, h2, h3, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.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 event information available at the time of this report.

• Brand Name: VERSA-DIAL 46X27X46 HUM HEAD
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10079277
• MDR Text Key: 194309669
• Report Number: 0001825034-2020-01919
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304460751
• UDI-Public: (01)00880304460751
• Combination Product (y/n): N
• PMA/PMN Number: K040610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113048
• Device Lot Number: 753240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2020
• 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: 105