MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHOULDER SYSTEMS : BIO-MODULAR SHOULDER HEADS AND GLENOIDS; PROSTHESIS - SHOULDER

Model Number N/A

Device Problem Loss of Osseointegration (2408)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Rozing, p.M.; nagels, j.; rozing, m.P.¿ (2010) prognostic factors in arthroplasty in the rheumatoid shoulder - received: 2 february 2010/accepted: 10 june 2010/published online: 14 july 2010 * the author(s) 2010.This article is published with open access at springerlink.Com; hssj (2011) 7: pp 29¿36; doi 10.1007/s11420-010-9172-1.The product was not available for return.Root cause could not be determined.Condition is addressed in the package insert.Part and lot identification necessary for review of device history records, and complaint history was not provided.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.Associated package insert 01-50-0944, there are warnings in the package insert that state that this type of event can occur, under possible adverse effects number 4 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption and/or excessive activity." 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.(b)(4).

Event Description

Information was received based on review of a journal article titled, "prognostic factors in arthroplasty in the rheumatoid shoulder¿.This article identified one (1) patient with an uncemented glenoid component experienced loosening.There has been no further information provided and the patient outcome is unknown.

• Brand Name: SHOULDER SYSTEMS : BIO-MODULAR SHOULDER HEADS AND GLENOIDS
• Type of Device: PROSTHESIS - SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6931029
• MDR Text Key: 89079022
• Report Number: 0001825034-2017-08251
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN BIO-MODULAR SHOULDER
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2014
• 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: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other