MAUDE Adverse Event Report: ANATOMICAL SHOULDER, REVERSE, SCREW SYSTEM, 4.5-42; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: anatomical shoulder, reverse, screw system, 4.5-36; catalog#: 01.04223.036; lot#: 2975326.Base plate 25 mm post length +2 mm lateral offset uncemented; catalog#: 00-4349-025-02; lot#: 64290315.Humeral stem 8 mm stem diameter 130 mm stem length; catalog#: 00-4349-008-13; lot#: 63202642.Glenosphere 36 mm diameter; catalog#: 00-4349-036-11; lot#: 64107257.Poly liner plus 0 mm offset 36 mm diameter; catalog#: 00-4349-036-00; lot#: 63761005.Palacos cement; catalog#: 66017747; lot#: 90624788.Therapy date: (b)(6) 2021.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the left side and underwent a revision surgery due to loosening of the trabecular metal baseplate supporting the glenosphere and implant fracture.
Additional Manufacturer Narrative
Investigation results were made available.Additional: h2, h6.Correction: b4, b5, g3, g6, h10.Review of event description: it was reported that the patient received an implant on (b)(6) 2019 and revised on (b)(6) 2021 due to implant fracture.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Radiology report review of the radiology reports was completed by a health care professional.This review identified a fracture of the second most proximal screw noted on (b)(6) 2020.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that the patient received an implant on (b)(6) 2019 and revised on (b)(6) 2021 due to implant fracture.Based on the investigation the reported event can be confirmed for one screw.However, as it is unknown which of the two screws fractured, the event cannot be confirmed for both devices.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
No event update.Investigation results are now available.

• Brand Name: ANATOMICAL SHOULDER, REVERSE, SCREW SYSTEM, 4.5-42
• Common Device Name: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• MDR Report Key: 12299894
• Report Number: 0009613350-2021-00393
• Device Sequence Number: 3807683
• Product Code: KWT
• UDI-Device Identifier: 00889024483057
• UDI-Public: 00889024483057
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.042
• Device Lot Number: 2967413
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 95