MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN GLENOID IMPLANT; PROSTHESIS, SHOULDER

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial right shoulder arthroplasty on an unknown date.Subsequently, on an unknown timeframe post-implantation, a custom implant request was submitted for a pending revision surgery of the glenoid component.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

(b)(4).D10: medical product: unknown bipolar head: catalog#ni, lot#ni.Unknown comprehensive stem: catalog#ni, lot#ni; unknown comprehensive adapter: catalog#ni, lot#ni.G2: foreign: germany.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Reported event was unable to be confirmed.If any further information is found 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 at time of this report.

• Brand Name: UNKNOWN GLENOID IMPLANT
• Type of Device: PROSTHESIS, SHOULDER
• 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: 19011500
• MDR Text Key: 339011752
• Report Number: 0001825034-2024-00901
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NI
• 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: 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/07/2024
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose