MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI TRAY STD COCR +6 OFFSET; PROSTHESIS, EXTREMITIES

Catalog Number	110031405
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-02661.Device product code - phx.Concomitant medical devices: item# 110031424; lot# 64862415; item# 115310; lot# 220420; item# 010000589; lot# 702460; item# 113632; lot# 65010218; item# 115396; lot# 105070; item# 180550; lot# 216920.Foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital discarded as a biohazard.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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
It was reported that the patient underwent an initial shoulder arthroplasty approximately two (2) months ago.Subsequently, the patient's shoulder dislocated and disassociated while trying to start a lawn mower.Patient reported hearing a noise and had the inability to move their arm.Patient was revised approximately one (1) month post-implantation.Upon opening the patient, it was discovered that the poly liner had dissociated from the humeral tray.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the explanted mini tray and humeral bearing.No further evaluation is possible from the photograph provided.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the glenosphere component is displaced from the glenoid base plate and remains aligned with the humeral tray and humerus, the latter both of which are displaced superiorly with respect to the glenoid base plate.Remaining hardware appears intact without periprosthetic abnormalities.Overall fit of the hardware is otherwise normal.No signs of loosening, wear, radiolucency, or contributing factors.No contributing factors that would lead to disassociation/dislocation 4 weeks postop.Bone quality is normal.No bone fracture detected.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report 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: MINI TRAY STD COCR +6 OFFSET
• Common Device Name: PROSTHESIS, EXTREMITIES
• 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: 12468193
• Report Number: 0001822565-2021-02660
• Device Sequence Number: 4853207
• Product Code: PHX
• UDI-Device Identifier: 00887868231377
• UDI-Public: (01)00887868231377(17)300819(10)64861497
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/26/2022

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 Catalogue Number: 110031405
• Device Lot Number: 64861497
• 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: 08/24/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2020
• 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: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 75 KG