MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 13MM MINI; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Fracture, Arm (2351)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 118001 versa-dial/comp ti std taper, lot 931920, 113034 versa-dial 42x21x43 hum head, lot 078680, 113633 comp primary stem, lot 880930, pt-113950 modular hybrid glenoid post¿ regenerex, lot 514000, 113952 modular hybrid glenoid base, lot 510140.Reported event was unable to be confirmed due to limited investigative inputs provided by the customer.Dhr was reviewed and no related manufacturing deviations or anomalies were identified.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.Still implanted.

Event Description

It was reported the patient was revised to address left total shoulder dislocation.Intra-operatively, a small fracture of the humerus was identified.It was not reported the stem was revised and it remains in situ.The patient was then implanted with a reverse total shoulder.No further information is available.

• Brand Name: COMP PRIMARY STEM 13MM MINI
• Type of Device: PROSTHESIS, EXTREMITY
• 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: 7934402
• MDR Text Key: 122673744
• Report Number: 0001825034-2018-08773
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060692
• 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
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• 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: 113633
• Device Lot Number: 880930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR