MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR 10MM HUM FRACT STEM PPS; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES

Model Number N/A

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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Osteopenia/ Osteoporosis (2651)

Event Date 10/22/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent a left shoulder revision due to bone fracture.The patient was treated by replacing the original humeral implant for bone fracture along with cerclage cables.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital did not release the product.The investigation is in process.Once the investigation has been completed, a follow up mdr will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional/corrected information.The following sections were updated: b4; b5; g1-2; g3; g6; h1; h2; h6.Upon receiving additional information, it was determined that the product should have not been reported and the initial report voided.

Event Description

It was reported that the patient underwent an initial left shoulder surgery on an unknown day for an unknown reason.Approximately two (2) years ago the patient was revised due to a bone fracture.Subsequently, the patient underwent the first stage of a revision approximately one (1) year and seven (7) months later due to an infection and bone loss that caused the implants to loosen and fracture.The underwent the second stage approximately three (3) months later to complete the revision.

• Brand Name: COMPR 10MM HUM FRACT STEM PPS
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14346017
• MDR Text Key: 291291002
• Report Number: 0001825034-2022-01180
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00880304591554
• UDI-Public: (01)00880304591554(17)290516(10)438080
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• 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: 12-113560
• Device Lot Number: 438080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• 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): Required Intervention; Hospitalization
• Patient Sex: Female