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

Catalog Number	115340
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4), d10: medical products: item#: xl-115364, arcom xl 44-36 std +3 hmrl brg; lot#: 875570.Item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: 436000.G2: foreign: china.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains in the patient.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 that the patient underwent an initial left shoulder reverse shoulder surgery and arthrocentesis approximately one (1) year and nine (9) months ago.Subsequently, the patient approximately two (2) weeks ago presented to the hospital with the implant fractured causing the patient's shoulder to dislocate.The x-rays were taken, and the surgeon recommended a revision surgery, but the patient has decided to not have the revision surgery at this time.
Event or Problem Description
It was reported that the patient underwent an initial left shoulder reverse shoulder replacement and arthrocentesis approximately two (2) years ago.Subsequently, two years after the initial reverse shoulder replacement and six (6) days after limitation of movement, the patient presented to the hospital with an examination report presenting a dislocated prosthesis with suspected fracture.The patient had charcot's arthroplasty and perceived pain impairment.The cause of the event is suspected to be due to the patient having charcot-arthropathy and pain the probable cause was excessive exercise.The patient underwent a revision surgery approximately two (2) months ago.There was no dislocation, only the tray was fractured.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; d2; d4; d6; d10, g2; g3; g6; h1; h2; h3; h4; h6 the following sections were corrected: b2, b5; d9 visual examination of the returned product identified the poly bearing was locked in the tray.The taper was fractured from the tray and remains in the humeral stem.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: initial post operative radiographs dated (b)(6) 2022 demonstrate anatomic alignment of a reverse-type left shoulder arthroplasty without complication.Skin staples are noted.Subsequent radiographs demonstrate a left shoulder arthroplasty dislocation with displacement of the humeral component from the humeral stem.No definite fracture is identified on this view.Implant fit appears maintained but there is malalignment secondary to humeral implant disassociation and dislocation.Bone quality is osteopenic.Patient anatomy and initial postoperative implant position are unremarkable.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 RVS HMRL TI TRAY 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: 19390961
• Report Number: 0001825034-2024-01353
• Device Sequence Number: 15189960
• Product Code: PHX
• UDI-Device Identifier: 00880304475335
• UDI-Public: (01)00880304475335(17)281217(10)599800
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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 Catalogue Number: 115340
• Device Lot Number: 599800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2018
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 68 KG