MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TM REVERSE SHOULDER SYSTEM POLY LINER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Concomitant medical product ¿ poly liner plus 3 mm offset 40 mm diameter, cat#: 00434904003 lot#: ni.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a shoulder arthroplasty, the humeral bearing would not lock properly into the stem.The surgeon replaced with a new bearing and the procedure completed with no delays.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Liner was returned for evaluation.Dimensions taken are within specifications.The device exhibits witness marks at the slot that accepts the anti-rotation boss of the stem.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.The witness marks around the slot that accepts the anti-rotation boss of the stem indicate that the liner was not suitably aligned with the antirotation boss of the stem and this likely caused the event.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: ZIMMER TM REVERSE SHOULDER SYSTEM POLY LINER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6604220
• MDR Text Key: 76398723
• Report Number: 0001822565-2017-03645
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00434904003
• Device Lot Number: 63541746
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 10/27/2017
• Supplement Dates FDA Received: 10/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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