MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED

Catalog Number UNKNOWN STEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Erosion (1750); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01351 and 0001825034-2023-01352.D10: item# unknown glenoid base; lot# unknown.Item# unknown humeral head; lot# unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.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 the patient underwent a right shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a pmi custom implant for an unknown reason.No revision procedure has been reported to date.Attempts have been made and no further information has been provided.

Event Description

It was reported that the patient underwent a right shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a pmi custom implant due to bone loss.No revision procedure has been reported to date.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6 upon reassessment of the reported event, it was determined to be not reportable as the patient has a vrs shoulder, in which a stem would not be implanted or involved in the reported event.The initial report was forwarded in error and should be voided.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.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED
• 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: 17166845
• MDR Text Key: 317531855
• Report Number: 0001825034-2023-01353
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193038
• 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: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 07/10/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female