MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS 25MM BSPLT HA+ADPTR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number 010000589

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

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

Event Date 05/09/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery due to the disassociation of implants.The patient underwent an initial left reverse shoulder arthroplasty approximately one (1) month prior to the implants disassociating.The cause of the implants disassociating is unknown at this time.

Manufacturer Narrative

(b)(4).Medical products: item#: 110031426, cr vivacit-e 36mm brng +3 ret; lot#: 64525929, item#: 110031400, mini tray +5mm cocr +0 offset; lot#: 65312082, item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 651310, item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 728930, item#: 180551, comp lk scr 3.5hex 4.75x20 st; lot#: 762870, item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: j7192927.Customer has indicated that the product will not be returned to zimmer biomet for investigation, it was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: implant disassembly with separation of the glenosphere from the base plate.No signs of loosening, wear, radiolucency, or contributing factors.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 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 RVRS 25MM BSPLT HA+ADPTR
• 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: 14604986
• MDR Text Key: 293381159
• Report Number: 0001825034-2022-01360
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304532465
• UDI-Public: (01)00880304532465(17)320216(10)613700
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 010000589
• Device Catalogue Number: 010000589
• Device Lot Number: 613700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male