MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM POLY LINER PLUS 3MM OFS; SHOULDER, PROSTHESIS

Model Number	00-4349-036-03
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign: (b)(6).36mm ã¿ glenosphere cat: 00434903611 lot: 64017088.Base plate uncemented cat: 00434903811 lot: 6406599.Tm reverse stem 16mm x 130mm cat: 00434901613 lot: 63897097.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.
Event or Problem Description
It was reported a patient underwent a shoulder arthroplasty.Subsequently, patient was revised due to dislocation.When the revision took place, the surgeon noticed the poly liner had been broken on the taper side, and was in the posterior of the shoulder joint.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g7, h1, h2, h3, h4, h6, h10.Visual examination of the provided photograph of the revised liner could not identify a fracture.The liner does show signs of wear and chip marks from use.No photograph was provided of the glenosphere.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the image on the left demonstrates dislocation of the humerus with respect to the glenosphere.Both images demonstrate normal appearance of the hardware without periprosthetic lucencies.The bones appear well mineralized on both images.As the polyethylene liner is radiolucent, no radiographic interpretation of the location or integrity of the polyethylene liner can be made.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: 36MM POLY LINER PLUS 3MM OFS
• Common Device Name: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13282999
• Report Number: 0001822565-2022-00086
• Device Sequence Number: 4835636
• Product Code: HSD
• UDI-Device Identifier: 00889024269064
• UDI-Public: (01)00889024269064(17)251231(10)63807788
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 04/19/2022

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 Expiration Date: 12/31/2025
• Device Model Number: 00-4349-036-03
• Device Catalogue Number: 00434903603
• Device Lot Number: 63807788
• 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: 12/22/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 102 KG