MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; SHOULDER, PROSTHESIS, REVERSE CONFIGURATION

Catalog Number UNKNOWN STEM

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00605, 0001822565-2023-00606, 0001822565-2023-00607, 0001822565-2023-00609.Device product code - phx patient was implanted on an unknown date in 2021.Item# 00434904011; lot# unknown.Item# 00434906606; lot# unknown.Item# unknown baseplate; lot# unknown.Item# unknown tray; lot# unknown.Foreign - event occurred in belgium customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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

It was reported that patient was revised approximately two years post-implantation due to shoulder dislocation, loosening of the poly and tray, disassociation of the taper adapter and baseplate, wear of the poly, and metallosis.X-rays were provided and reviewed by a healthcare professional.It was noted that there is also regional soft tissue swelling and bone quality is osteopenic.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: proposed component code - mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is inferior dislocation and glenosphere displacement as noted.Implant fit is maintained.Bone quality is osteopenic.The humeral implant is dislocated inferior to the remaining baseplate.There is no osseous fracture and no evidence of implant loosening.There is regional soft tissue swelling.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report 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: UNKNOWN STEM
• Type of Device: SHOULDER, PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16514132
• MDR Text Key: 311038478
• Report Number: 0001822565-2023-00608
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN STEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2023
• 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 Sex: Prefer Not To Disclose