MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X15 ST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number 180550

Device Problems Material Erosion (1214); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Erosion (1750); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530)

Event Date 05/11/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a right shoulder reverse total shoulder arthroplasty approximately seven (7) years and five (5) months ago, subsequently, the patient underwent a revision surgery due to metalosis of the implants.The patient is scheduled for a second revision surgery in approximately three (3) weeks to implant custom implants and complete the revision.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01268, 0001825034-2023-01269, 0001825034-2023-01270, 0001825034-2023-01271, 0001825034-2023-01273, 0001825034-2023-01274, 0001825034-2023-01283.D10: medical products: item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: 293460.Item#: 115370, comp rvs tray co 44mm; lot#: 417500.Item#: ep-115393, e1 44-36 std hmrl brng; lot#: 520070.Item#: 115396, comp rvs cntrl 6.5x30mm st/rst; lot#: 583320.Item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 890170.Item#: 180557, comp nlk scr 3.5hex 4.75x15 st; lot#: 540130.Item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 697110.H3: product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

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: 0001825034-2023-01268-1, 0001825034-2023-01269-1, 0001825034-2023-01270-1, 0001825034-2023-01271-1, 0001825034-2023-01273-1, 0001825034-2023-01274-1, 0001825034-2023-01283-1.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient had a right reverse total shoulder arthroplasty.Subsequently, the patient began to experience pain, mechanical instability, and a clunking sensation.Radiographic imaging displayed disassociation of the implant and the patient underwent a revision surgery approximately seven and half years after the initial surgery.During the surgery it was found that there was severe metallosis throughout the joint and erosion and severe osteolysis to the glenoid.Due to bone stock of the glenoid the surgeon performed the first stage of a two-stage revision surgery.All implants were revised except for the humeral stem as it was well fixed and a antibiotic spacer was placed until the stage two revision could be completed.All implants were revised except the humeral stem as it was well fixed, and an antibiotic spacer was implanted.

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 corrected information.Upon reassessment of the reported event, it was determined that the product was not the direct cause of the event.The initial report should be voided.

• Brand Name: COMP LK SCR 3.5HEX 4.75X15 ST
• 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: 17073052
• MDR Text Key: 316661752
• Report Number: 0001825034-2023-01272
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304677135
• UDI-Public: (01)00880304677135(17)251209(10)365550
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130390
• 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,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 180550
• Device Catalogue Number: 180550
• Device Lot Number: 365550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2015
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female