MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PT HYBRID GLEN POST REGENEREX; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES

Model Number PT-113950

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 07/19/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01922-1.0001825034-2022-01923-1.Concomitant medical products: item#: 113042, versa-dial 46x18x53 hum head; lot#: 190190, item#: 118001, versa-dial/comp ti std taper; lot#: 814790, item#: 113630, comp primary stem 10mm mini; lot#: 992200, item#: 113954, md hybrid glenoid base 4mm; lot#: 899530.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.Visual examination of the provided picture identified that product has been explanted and is till assembled to mating implant.Part and lot numbers cannot be confirmed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided; however, they were not submitted for review as the images are in the immediate postop timeframe as reflected by the staple line present.Sending the images would not enhance the investigation.Images taken (b)(6) 2017.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 that a patient underwent an initial right shoulder arthroplasty.Subsequently, approximately seven (7) years later, the patient was revised due to loosening of implants and an infection.All components were removed and replaced with an antibiotic cement spacer.

• Brand Name: PT HYBRID GLEN POST REGENEREX
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• 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: 15946090
• MDR Text Key: 305137932
• Report Number: 0001825034-2022-02758
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00880304459854
• UDI-Public: (01)00880304459854(17)270104(10)370430
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT-113950
• Device Catalogue Number: PT-113950
• Device Lot Number: 370430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2017
• 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: 64 YR
• Patient Sex: Female