MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLY LINER PLUS 6 MM OFFSET 36 MM DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Difficult to Insert (1316); Fitting Problem (2183)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has been 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 mdr will be submitted.

Event Description

It was reported that when the surgeon went to implant the poly the middle cut did not fit with the square block on the stem.A new poly was opened and used.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Cmp-(b)(4).The following report is submitted to relay additional information updated: corrected: the reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this 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: POLY LINER PLUS 6 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: 7007688
• MDR Text Key: 92323709
• Report Number: 0001822565-2017-07690
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK130661
• 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
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• 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: 00434903606
• Device Lot Number: 63622891
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2017
• 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