MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM 8 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS, SHOULDER

Catalog Number 00434900813

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

Patient Problem Ossification (1428)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product code: phx.Udi: (b)(4).Concomitant products: item# 0104223042; lot# 2967413; anatomical shoulderâ¿¢ reverse, screw system, 4.5-42 ; item# 0104223036; lot# 2975326; anatomical shoulderâ¿¢ reverse, screw system, 4.5-36 ; item# 00434903611; lot# 64107257; glenosphere 36 mm diameter ; item# 00434903600; lot# 63761005; poly liner plus 0 mm offset 36 mm diameter ; item# 66017747; lot# 90624788; palacos cement ; item# 00434902502 ; lot# 64290315 ; base plate 25 mm post length +2 mm lateral offset uncemented.Report source: foreign: event occurred in (b)(6).Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: implants were well positioned post procedure with radiolucency noted around the screws.The implant position remain unchanged in the weeks following the procedure with no loosening or fracture of implant or bone.Heterotropic ossification was noted approximately 6 months post procedure.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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.

Event Description

It was reported patient underwent a revision procedure 14 months post implantation due to loosening of the baseplate.Heterotopic ossification and anteversion of the glenoid component were also reported.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.

• Brand Name: HUMERAL STEM 8 MM STEM DIAMETER 130 MM STEM LENGTH
• 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: 12270639
• MDR Text Key: 264921270
• Report Number: 0001822565-2021-02177
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00889024258913
• UDI-Public: (01)00889024258913(17)251031(10)63202642
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00434900813
• Device Lot Number: 63202642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 95