MAUDE Adverse Event Report: ANATOMICAL SHOULDER, REVERSE, SCREW SYSTEM, 4.5-33; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994)
Date of Event	05/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: anatomical shoulder reverse, screw system, 4.5-36; catalog#: 01.04223.036; lot#: 2941140.Base plate 15 mm post length uncemented; catalog#: 00-4349-015-00; lot#: 64141394.Poly liner plus 0 mm offset 36 mm diameter; catalog#: 00-4349-036-00; lot#: 64063103.Humeral stem 10 mm stem diameter 130 mm stem length; catalog#: 00-4349-010-13; lot#: 63867841 poly liner plus 0 mm offset 36 mm diameter; catalog#: 00-4349-036-00; lot#: 64422521 therapy date: (b)(6) 2021.The manufacturer received x-rays for review.Other documents were received and will be reviewed as part of ongoing investigation.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 an unknown side and underwent a revision surgery due to pain and infection.
Event or Problem Description
No event update.Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.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 pain and infection.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.- x-rays: the provided x-ray was not reviewed as the complaint is for infection, which is not visible on x-rays.- patient data: the provided lab results were reviewed and it was found the patient had proprione acnes, a type of gram-positive bacteria.The patient was treated with an antibiotic orally and by iv.The provided medical history of the patient identified a previous deep infection in 2018 resulting in finger amputations.Product evaluation: visual examination: the visual examination shows no signs of damage on either device.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.- sterilization certificate: the eto/ gamma sterilization specification of the device certifies the suitability of sterilization.The irradiation certificate of the affected lot number has been reviewed and was found to be according to specifications.Conclusion: it was reported that the patient received an implant on (b)(6), 2019 and revised on (b)(6), 2021 due to pain and infection.Sterilization 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.Based on the investigation the reported event cannot be confirmed.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).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).

• Brand Name: ANATOMICAL SHOULDER, REVERSE, SCREW SYSTEM, 4.5-33
• Common Device Name: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• MDR Report Key: 12007871
• Report Number: 0009613350-2021-00284
• Device Sequence Number: 3059361
• Product Code: KWT
• UDI-Device Identifier: 00889024483033
• UDI-Public: 00889024483033
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 11/03/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.033
• Device Lot Number: 2910488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2017
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 78