MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 50X24X52 HUM HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Disconnection (1171); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Disorder (2373)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that 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.Concomitant medical products: 118001, versa-dial/comp ti std taper, 016610, 113633, comp primary stem 13mm mini, 283780, 113954, md hybrid glenoid base 4mm, 095580, pt-113950, pt hybrid glen post regenerex, 865440.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 07689.

Event Description

It was reported that the patient underwent an initial shoulder arthroplasty procedure due to osteoarthritis.Subsequently, the patient experienced worsening subluxation following a pectoralis tendon transfer procedure.It is also reported that the patient has pain on both the anterior - superior and anterior - lateral sides.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to 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.

• Brand Name: VERSA-DIAL 50X24X52 HUM HEAD
• 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: 6909232
• MDR Text Key: 87999340
• Report Number: 0001825034-2017-07688
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060716
• 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,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• 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: 113055
• Device Lot Number: 792010
• Other Device ID Number: (01) 0 0880304 46159 8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• 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): Hospitalization; Other
• Patient Age: 56 YR
• Patient Weight: 105