MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR PROLONG 40MM BRNG STD; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	110031421
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.D10: medical products: item#: 110031421, cr prolong 40mm brng std; lot#: 65740969.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 that a patient underwent an initial shoulder arthroplasty on an unknown date.Subsequently, the patient underwent a revision surgery due to the implants disassociating which was caused by the patient raising their arm while seated and placing their arm on top of their couch.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
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: visual examination of the returned product identified the bearing is locked onto the tray.Damage is seen in the spherical radius of the poly bearing and surface scuffs are seen on the rim of the tray.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (b)(6) 2022: single view of the right shoulder demonstrates oblique appearance of the glenohumeral joint.A right total shoulder arthroplasty is present but evaluation of the hardware in the joint space is limited given obliquity.No fracture is seen.(b)(6) 2023: single view of the right shoulder demonstrates a right total shoulder arthroplasty with no obvious dislocation seen.No radiolucency.No bony fracture.Evaluation of the joint space is limited given single view.Impressions: right total shoulder arthroplasty without evidence for dislocation or humeral tray and bearing dissociation.Evaluation is limited given single view on both dates of imaging.Overall fit and alignment of the implants is appropriate, but evaluation is significantly limited given single view of the right shoulder on both dates of imaging.No signs of loosening, wear, radiolucency, or any other contributing factor such as malalignment that would cause issues with any of the components on the x-ray.No implant or anatomical concerns that would lead to revision.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: CR PROLONG 40MM BRNG STD
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• 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: 16984642
• Report Number: 0001822565-2023-01396
• Device Sequence Number: 6771698
• Product Code: PHX
• UDI-Device Identifier: 00887868231520
• UDI-Public: (01)00887868231520(17)280117(10)65740969
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 10/13/2023

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 Model Number: 110031421
• Device Catalogue Number: 110031421
• Device Lot Number: 65740969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• 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: 05/01/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male