MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 10MM ÿ 130MM LENGTH HUMERAL STEM; PROSTHESIS, SHOULDER, REVERSE CONFIGURATION

Catalog Number 00434901013

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Rheumatoid Arthritis (1724); Erosion (1750); Failure of Implant (1924); Loss of Range of Motion (2032); Osteolysis (2377)

Event Date 05/14/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a right shoulder arthroplasty approximately seven (7) years ago.Subsequently, at the patient's seven (7) year follow-up appointment, x-rays taken noted osteolysis in the humeral head, bone resorption, glenoid and humeral loosening.Patient has been taking pain relief medication, but no other intervention is planned due to severe rheumatoid arthritis and poor bone stock.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01625, 0001822565-2023-01642.D10: item#: 00434902502; lot#: 62514115.Item#: 00434903600; lot#: 63028247.Item#: 00434903611; lot#: 63076788.G2: foreign: event occurred in the uk.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Proposed annex g code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent reverse shoulder on (b)(6) 2016.Subsequently, on (b)(6) 2023, at 7-year follow-up appointment x-ray show osteolysis humeral head, bone reabsorption, glenoid loosening, and humeral loosening.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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: 10MM ÿ 130MM LENGTH HUMERAL STEM
• Type of Device: PROSTHESIS, SHOULDER, 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: 17152296
• MDR Text Key: 317464937
• Report Number: 0001822565-2023-01624
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00434901013
• Device Lot Number: 63012698
• 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
• Date Device Manufactured: 06/01/2015
• 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): Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 70 KG