MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOID COMPONENT KEELED 52 MM DIAMETER ARTICULAR SURFACE; SHOULDER, PROSTHESIS

Catalog Number 00430004652

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

Patient Problem Tissue Damage (2104)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: offset modular humeral head 19 mm head height 52 mm spherical head diameter, cat: 00430205219, lot: 61470566.Humeral stem 48 degrees 13 mm stem diameter 130 mm stem length, cat: 00434811313, lot: 62502901.Report source: foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported the patient underwent a primary shoulder replacement.Subsequently, the patient developed rotator cuff pathology resulting in a revision due to proximal migration of humeral head and subsequent loosing of the glenoid implant.There was no loosing of the humeral head or stem noted.

Manufacturer Narrative

Visual examination of the provided pictures identified blood stains on humeral head and glenoid.Bone appeared on the back of the glenoid.Stem was explanted and has bone on the porous part of the stem.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: "tsr 4 years ago prosthesis in situ however marked proximal humeral head migration of the prosthesis." device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

No further event information available at the time of this report.

• Brand Name: GLENOID COMPONENT KEELED 52 MM DIAMETER ARTICULAR SURFACE
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10246237
• MDR Text Key: 199455188
• Report Number: 0001822565-2020-02480
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 00430004652
• Device Lot Number: 62168849
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention