MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE NON-LOCKING SCREW; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 05/28/2014

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).Report source: foreign: the event occurred in (b)(6).The device was not returned for evaluation due to unknown location.Review of the device history record (dhr) found no deviations or anomalies.Review of complaint history for same issue identified two complaints for part (catalog) number and no complaints identified for lot number.Without the opportunity to evaluate the device, the complaint was not confirmed and root cause could not be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Associated risk table lists "miscellaneous user needs (general post-operative pain )¿.Following review, no new risks were identified.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-11063/11064/11065/11067/11068/11069/11070/11071.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that following an unspecified shoulder procedure on (b)(6) 2014, a female patient indicated at the one year follow up visit that she experienced problems with usual work and moderate pain.No further information was provided and patient's outcome is unknown.Attempts to obtain further information were performed, yet no additional information was provided.

Manufacturer Narrative

It has been determined that this report was submitted in error; therefore, we are rejecting the report.

• Brand Name: COMPREHENSIVE NON-LOCKING SCREW
• 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: 7113411
• MDR Text Key: 94699487
• Report Number: 0001825034-2017-11074
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

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?: No
• Device Operator: Physician
• Device Expiration Date: 01/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 180510
• Device Lot Number: 445960
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 05/28/2014
• Supplement Dates FDA Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2013
• 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: 91 YR
• Patient Weight: 55