MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Pain (1994); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00434903611 glenosphere 36 mm diameter 63028198/63040114; 00434902502 base plate 25 mm post length +2 mm lateral offset uncemented 63175602; 0104223024 anatomical shoulderâ?¢ reverse, screw system, 4.5-24 2740051; 0104223036 anatomical shoulderâ?¢ reverse, screw system, 4.5-36 2831766; 00434901213 humeral stem 12 mm stem diameter 130 mm stem length 63108407.Report source- foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01019; 0001822565 - 2019 - 01021.

Event Description

It was reported that the patient had initial shoulder arthroplasty and subsequently underwent a revision due to glenoid loosening and dislocation, causing restricted range of motion and pain, with secondary polyethylene wear two (2) years, ten(10) months post implantation.No additional information is available at this time.

Event Description

No additional information is available to report at this time.

Manufacturer Narrative

The following report is being submitted to relay additional information received: the complaint is confirmed based on the photograph of the explants.Review of photographs shows the glenosphere remained assembled to the baseplate along with the screws.Tissue and blood are observed on the post of the baseplate.The poly liner showed wear, possibly happened due to dislocation.Blood stains are observed on the liner.Blood and tissue was observed on the stem.X-rays provided were reviewed stating loosening of the glenoid component with malposition and loosening of the humeral component with subluxation with respect to the glenoid component, which may relate to polyethylene wear.Dhr was reviewed and no discrepancies were found.A definite root cause cannot be determined with the information provided.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.

• Brand Name: POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8392492
• MDR Text Key: 137931745
• Report Number: 0001822565-2019-01018
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00434903600
• Device Lot Number: 63152436
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention