MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM XL 44-36 RTNV+3 HMRL BRG; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number XL-115365

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374); Insufficient Information (4580)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02544, 0001825034-2022-02545 and 0001825034-2022-02546.Concomitant medical products: item#: ti-115310, comp vrsdl glnspr 36mm ti, lot#: 621130, item#: 010000589, comp rvrs 25mm bsplt ha+adptr, lot#: 634750, item#: 115340, comp rvs hmrl ti tray 44mm, lot#: 738490, item#: 113633, comp primary stem 13mm mini, lot#: 336010, item#: 180553, comp lk scr 3.5hex 4.75x30 st, lot#: 628290, item#: 180553, comp lk scr 3.5hex 4.75x30 st, lot#: 628290, item#: 115394, comp rvs cntrl 6.5x20mm st/rst, lot#: 011400.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a left shoulder revision surgery approximately one (1) week after undergoing an initial revision surgery due to an unknown reason.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02544-1.0001825034-2022-02545-1.0001825034-2022-02546-1.0001825034-2022-02567-1.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot 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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02544-2; 0001825034-2022-02545-2; 0001825034-2022-02567-2.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 Description

It was reported that approximately 1 month post implantation, the patient was revised due to loosening and dislocation of their shoulder arthroplasty products.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02544-3, 0001825034-2022-02545-3, 0001825034-2022-02567-3.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Previous root cause remains unchanged, a definitive root cause cannot 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.

Event Description

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

• Brand Name: ARCOM XL 44-36 RTNV+3 HMRL BRG
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15770645
• MDR Text Key: 303412207
• Report Number: 0001825034-2022-02547
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304475519
• UDI-Public: (01)00880304475519(17)221026(10)361080
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2022
• Device Model Number: XL-115365
• Device Catalogue Number: XL-115365
• Device Lot Number: 361080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention