MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER SYSTEM PROLONG HIGHLY CROSSLINKED POLYETHYLENE BE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110031421
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Subluxation (4525); Metal Related Pathology (4530)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.D10: concomitant medical products, part (lot): -110030776 (65569143).Associated product information: -115398 (66019913).-180552 (66352062).-180551 (66501621).-180551 (66495838).-180552 (65832948).-113636 (66002557).-110031399 (66421228).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was unavailable by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that a patient had an initial reverse right total shoulder arthroplasty.Subsequently, the patient was revised approximately 1 year post-surgery due to pain, decreased range of motion, and subluxation of implants identified on xray.During the revision, the surgeon noted that the glenosphere had become dislodged from the baseplate with significant damage noted to the baseplate and metallosis around the joint.The humeral stem was well-fixed and left intact.All other components were replaced without complication.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d9; g1; g3; g4; g6; h1; h2; h3; h6; h10.The reported event is confirmed through provided photos and review of medical records.Visual examination of the provided pictures identified a bearing, screws, glenopshere with taper attached, and baseplate with extractor all with debris.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: radiology report; acetabular component is displaced (subluxed) superiorly compared to the prior exam.Some periarticular spurring.Soft tissues unremarkable.H&p patient reports increased pain and decreased rom.X-rays showed sublux implant; revision op note, wvu medicine; glenoid exposure obtained, ¿the glenosphere was not in the base plate and was easily removed.It had become dislodged from the baseplate.Inspection of the baseplate showed there was significant damage and there was some metallosis around the joint.¿ baseplate and all screws removed with no bone loss.A definitive root cause cannot be determined.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER SYSTEM PROLONG HIGHLY CROSSLINKED POLYETHYLENE BE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22868438
• Report Number: 0001822565-2025-03031
• Device Sequence Number: 20745748
• Product Code: PHX
• UDI-Device Identifier: 00887868231520
• UDI-Public: (01)00887868231520(17)280305(10)65808969
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: Lay User/Patient
• Device Catalogue Number: 110031421
• Device Lot Number: 65808969
• Was Device Available for Evaluation?: No
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White