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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Tingling (2171); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product - unknown glenoid head # ni lot # ni.Unknown stem catalog # ni lot # ni.Unknown tm base plate catalog # ni lot # ni.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr repots were filled for this event: 0001822565 - 2017 - 06054, 0001822565 - 2017 - 06052, 0001822565 - 2017 - 06056.

Event Description

It was reported that patient underwent total reverse shoulder procedure and is experiencing tingling, pain and discomfort.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Concomitant medical products: 00434901213, humeral stem, 62316674.The 00434903611, glenosphere 36 mm diameter, 62304086.The 00434901500, base plate 15 mm, 62323920.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-06052-1, 0001822565-2017-06054-1, 0001822565-2017-06056-1.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.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 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.

• Brand Name: POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER
• 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: 6821743
• MDR Text Key: 83687473
• Report Number: 0001822565-2017-06055
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00434903600
• Device Lot Number: 62232563
• Other Device ID Number: N/A
• 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: 12/26/2012
• 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 Weight: 53