MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 44-36 STD HMRL BRNG; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Unspecified Tissue Injury (4559)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 260670.Catalog #: 115370, comp rvs tray co 44mm, lot # 631750.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital would not return the device.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02941, 0001825034-2021-02942.
Event or Problem Description
It was reported that there was a revision of a comprehensive reverse shoulder for pain associated with impingement.Attempts have been made and there is no further information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4) reported event was confirmed as radiographs were reviewed and it was found that the lateral down sloping acromion could contribute to the roator cuff impingement.No hardware failure was found.Visual examination of the provided pictures identified marks and signs of use from being implanted and explanted.No definitive statements can be made regarding the condition of the products relating to the patient's pain.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.

• Brand Name: E1 44-36 STD HMRL BRNG
• Common Device Name: PROSTHESIS SHOULDER
• 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: 12693695
• Report Number: 0001825034-2021-02943
• Device Sequence Number: 1480103
• Product Code: KWS
• UDI-Device Identifier: 00880304543157
• UDI-Public: (01)00880304543157(17)240522(10)981780
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193373
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

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: Health Professional
• Device Expiration Date: 05/22/2024
• Device Model Number: N/A
• Device Catalogue Number: EP-115393
• Device Lot Number: 961780
• 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: 10/05/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2019
• 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 Sex: Female