MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE 15 MM POST LENGTH UNCEMENTED; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Tissue Damage (2104); Joint Dislocation (2374)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown humeral stem; 00434903611 glenosphere 36 mm diameter 64142472; 00434903600 poly liner plus 0 mm offset 36 mm diameter 64008407; 0104223024 anatomical shoulderâ?¢ reverse, screw system, 4.5-24 2900484; 0104223030 anatomical shoulderâ?¢ reverse, screw system, 4.5-30 2901383.Customer has indicated that the product will not be returned to zimmer biomet for investigation, discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial left shoulder arthroplasty and was revised due to glenoid fracture and bone loss, with subsequent loosening and dislocation two weeks post implantation.No additional information is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Udi #: (b)(4).Customer has indicated that the product will not be returned because it was discarded.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Dhr was reviewed and no discrepancies relevant to the reported event were found.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: BASE PLATE 15 MM POST LENGTH UNCEMENTED
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8499437
• MDR Text Key: 141461827
• Report Number: 0001822565-2019-01279
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00434901500
• Device Lot Number: 64057093
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 74