MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PT HYBRID GLEN POST REGENEREX; PROSTHESIS EXTREMITY

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient received an initial total comprehensive shoulder prothesis.An x-ray taken after 5 years of the initial surgery show that the central post is broken and separated from the polyethylene glenoid component.The reason for why the central post is broken off from the polyethylene glenoid is unknown.Implants are still in the patient.
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 118001, versa-dial/comp ti std taper, lot # 438720.Catalog #: 113034, versa-dial 42x18x46 hum head, lot # 395350.Catalog #: 113633, comp primary stem 11mm mini, lot # 805910.Catalog #: 113952, md hybrid glenoid base 4mm, lot # 804850.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains in patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: suboptimal interpretation without annotation is indicating the date of images.None of the images are labeled and therefore interpretation is poor.Additionally, image 1 is suboptimally positioned.Secondary to suboptimal positioning, assessment for breakage of the central post on image 1 is poor.The glenoid component overlies the scapula and proximal component of the coracoid process.Assessment for alignment of the central pelvis with respect to the glenoid is poor.Image 2 shows slight superior angulation of the articular region of the central post, potentially representing the event/deficiency description.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: PT HYBRID GLEN POST REGENEREX
• Common Device Name: PROSTHESIS EXTREMITY
• 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: 14681204
• Report Number: 0001825034-2022-01398
• Device Sequence Number: 14611339
• Product Code: HSD
• UDI-Device Identifier: 00880304459854
• UDI-Public: (01)00880304459854(17)270106(10)814960
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PT-113950
• Device Lot Number: 814960
• 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: 05/16/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown