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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MD HYBRID GLENOID BASE 4MM; SHOULDER PROSTHESIS, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES

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ZIMMER BIOMET, INC. MD HYBRID GLENOID BASE 4MM; SHOULDER PROSTHESIS, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES Back to Search Results
Model Number 113630
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  
Event Description
It was reported that a patient underwent an initial right shoulder arthroplasty.Subsequently, approximately seven (7) years later, the patient is was revised due to loosening of implants and a infection.All components were removed and replaced with an antibiotic cement spacer.
 
Manufacturer Narrative
(b)(4) multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01922.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.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but per hospital policy was not returned.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 information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01922-1 0001825034-2022-02758 d10: medical products: item#: pt-113950, pt hybrid glen post regenerex; lot#: 370430.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 the product has been explanted and still assembled to mating implant.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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 08-feb-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
No further event information available at the time of this report.
 
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Brand Name
MD HYBRID GLENOID BASE 4MM
Type of Device
SHOULDER PROSTHESIS, 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 Key15300032
MDR Text Key298665505
Report Number0001825034-2022-01923
Device Sequence Number1
Product Code MBF
UDI-Device Identifier00887868267772
UDI-Public(01)00887868267772(17)261130(10)992200
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/07/2022
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? Yes
Device Operator Health Professional
Device Expiration Date07/21/2021
Device Model Number113630
Device Catalogue Number113954
Device Lot Number899530
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/01/2022
Initial Date FDA Received08/26/2022
Supplement Dates Manufacturer Received12/06/2022
Supplement Dates FDA Received12/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
Patient SexFemale
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