MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS TRAY CO 44MM; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Unspecified Tissue Injury (4559)

Event Date 10/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 260670.Catalog #: ep-115393, e1 44-36 std hmrl brng, lot # 961780.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 and 0001825034-2021-02943.Requested but not returned by hospital.

Event 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 Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Updated: b4, b5, g3, h1, h2, h3, h6, h10.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: COMP RVS TRAY CO 44MM
• Type of Device: 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: 12693616
• MDR Text Key: 278338685
• Report Number: 0001825034-2021-02942
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304543201
• UDI-Public: (01)00880304543201(17)290612(10)631750
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115370
• Device Lot Number: 631750
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female