MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X35MM ST/RST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 115397

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  Injury  

Event Description

It was reported a patient underwent a right shoulder revision due to malposition of the device.All components except the humeral stem were removed and replaced with an anatomic shoulder system.It was noted the patient will undergo another revision; however, the date and procedure are yet to be determined.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Zimmer biomet will continue to monitor for trends.Associated products and reports: 0001825034-2023-01188, item#110027734; lot#652460; 0001825034-2023-01189, item#180551; lot#unk; 0001825034-2023-01190, item#180551; lot#unk; 0001825034-2023-01191, item#180552; lot#unk; 0001825034-2023-01192, item#180552; lot#unk.Other associated products: item#110031424; lot#65425320; item#110031401; lot#64490866; item#115310; lot#j7280809; item#110031378; lot#652480; item#113650; lot#65213817; item#405889; lot#5845203; item#110028045; lot#016680; item#110019066; lot#652490.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the glenoid component appears to be inferomedially displaced from the glenoid fossa and the central screw appears extraosseous.However, the glenoid and humeral implants are maintained in alignment.There is no fracture identified.Correlation with earlier images would be of value in determining interval change in implant position.Bone quality is osteopenic.The glenoid implant appears loose and displaced but correlation with earlier images would be of value.A definitive root cause cannot be determined.The reported event is confirmed by mmi review.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 is available at the time of this report.

• Brand Name: COMP RVS CNTRL 6.5X35MM ST/RST
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16993231
• MDR Text Key: 315866002
• Report Number: 0001825034-2023-01193
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115397
• Device Lot 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: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female