MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 42X18X46 HUM HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Date 11/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: us-115732, compr nano hmrl pps 32mm, 402810.118001, versa-dial/comp ti std taper, 079030.113952, sm hybrid glenoid base 4mm, 817120.Pt-113950, pt hybrid glen post regenerex, 376020.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 11326, 0001825034 - 2017 - 11325, 0001825034 - 2017 - 11328, 0001825034 - 2017 - 11329.

Event Description

It was reported that the patient underwent shoulder surgery.Subsequently, the patient is experiencing pain and instability in the operative shoulder.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required 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.

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that patient had initial comprehensive shoulder arthroplasty.Subsequently, patient had severe pain and instability two and half years post initial surgery.Severe pain and instability was again reported at three (3) year doctor's visit.Shoulder popping in operative shoulder due to instability was reported (7) seven days post (3) three year visit.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Additional information was reviewed and assessed.The new allegations of pain/instability and shoulder popping at 3 years were not previously addressed on this complaint; however, the patient had previous reports of pain and instability which were adequately addressed.No revision has been reported to date.Risk assessment has been updated with the current rmf files.No further changes to the investigation are deemed necessary at this time.

Event Description

No further event information available at the time of this report.

• Brand Name: VERSA-DIAL 42X18X46 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: 7133862
• MDR Text Key: 95358768
• Report Number: 0001825034-2017-11327
• 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: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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: 113032
• Device Lot Number: 947100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2014
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 55 YR
• Patient Weight: 61