MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS TRAY CO 44MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	115370
Medical Device Problem Codes	Material Erosion (1214); Naturally Worn (2988)
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right shoulder reverse total shoulder arthroplasty approximately seven (7) years and (b)(6) 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.
Additional Manufacturer Narrative
(b)(4) multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01268, 0001825034-2023-01270, 0001825034-2023-01271, 0001825034-2023-01272, 0001825034-2023-01273, 0001825034-2023-01274, 0001825034-2023-01283.D10: medical products: item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: 293460, 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, 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.
Event or Problem 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 wear to the implant, 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.
Additional 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 , 0001825034-2023-01270-1, 0001825034-2023-01271-1, 0001825034-2023-01272-1, 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.
Additional 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP RVS TRAY CO 44MM
• Common Device Name: 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: 17072920
• Report Number: 0001825034-2023-01269
• Device Sequence Number: 12285807
• Product Code: PHX
• UDI-Device Identifier: 00880304543201
• UDI-Public: (01)00880304543201(17)251230(10)417500
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2023

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 Expiration Date: 12/30/2025
• Device Model Number: 115370
• Device Catalogue Number: 115370
• Device Lot Number: 417500
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 06/07/2023; 12/12/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/29/2023; 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female