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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930); Osteopenia/ Osteoporosis (2651)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0001825034-2022-01180
• Device Sequence Number: 5270706
• Product Code: MBF
• UDI-Device Identifier: 00880304591554
• UDI-Public: (01)00880304591554(17)290516(10)438080
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female