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

Model Number 010000589

Device Problems Material Erosion (1214); Unstable (1667); 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, 0001825034-2023-01272, 0001825034-2023-01273, 0001825034-2023-01274.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#: 180550, comp lk scr 3.5hex 4.75x15 st; lot#: 365550, item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 890170, item#: 180557, comp nlk scr 3.5hex 4.75x15 st; lot#: 540130.H3: 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.

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, 0001825034-2023-01272-1, 0001825034-2023-01273-1, 0001825034-2023-01274-1.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, loosening of the baseplate, 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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and corrected information.Visual examination of the returned product identified the baseplate has wear on the face of the part.Taper adapter shows heavy signs of damage and a v-shape wearing of the metal.Other devices explanted show signs of use and wear.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: may 11, 2023, op note: significant findings during the surgery include severe metallosis throughout the shoulder joint, loosening of the baseplate, crescent pattern wear to the poly, v-shaped wear to the trunnion, and erosion and severe osteolysis to the glenoid.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a reverse type right shoulder arthroplasty is present.There is abnormal alignment of the glenosphere with the baseplate consistent with glenosphere disassociation.There is no osseous fracture, evidence of implant loosening, or abnormal radiolucency.Bone quality is osteopenic.Implant fit is maintained.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: 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: 17073066
• MDR Text Key: 316754674
• Report Number: 0001825034-2023-01283
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304532465
• UDI-Public: (01)00880304532465(17)251209(10)697110
• 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,Followup
• Report Date: 12/21/2023

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: 010000589
• Device Catalogue Number: 010000589
• Device Lot Number: 697110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female