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

Model Number N/A

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the surgeon felt he had to use excessive force to engage the liner locking mechanism with the stem during a right shoulder surgery.The liner failed to properly engage stem and subsided, becoming unstable.The surgery was completed with another device.No delay to surgery or consequences to the patient were reported.

Manufacturer Narrative

Concomitant medical products: 00434900813 63881498 humeral stem 8 mm stem diameter 130 mm stem length.00434906500 63600791 retentive poly liner plus (+) 0 mm offset 36 mm diameter 65 degree neck angle.00434901500 63702711 base plate 15 mm post length sterile product do not resterilize.00434903611 63697059 glenosphere 36 mm diameter.01.04223.048 2816124 invers/revers scr syst 4.5-48.01.04223.036 2830810 invers/revers scr syst 4.5-36.Complaint sample was evaluated and the reported event was confirmed.Indentations were observed.Anti-rotation slot does not show any misalignment marks.Dimensions are within specifications.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined.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.

• 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
• 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: 6869914
• MDR Text Key: 86456293
• Report Number: 0001822565-2017-06494
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00434903600
• Device Lot Number: 63672029
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 03/06/2018; 03/06/2018
• Supplement Dates FDA Received: 03/06/2018; 03/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2017
• 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
• Patient Age: 77 YR