MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STANDARD 40MM DIAMETER BEARING; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	110031427
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial shoulder arthroplasty twenty-eight (28) days ago.Subsequently, three (3) days after their initial surgery the patient was revised due to the implants dislocating.
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 110030776, standard offset 40mm diameter glenosphere; lot#: 66783629.G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested from the hospital but not returned by the hospital.The investigation is in process.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 additional information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6 product has not been returned.No product evaluation was able to be completed.It was reported that a patient experienced scar tissue resulting in dislocation of the shoulder joint due to chronic flail arm syndrome (fas).Fas occurs from chronic weakness and muscle atrophy, often due to underlying comorbid conditions or neurological disorders that prevent full arm movement and muscle strengthening.Scar tissue then develops as the body attempts to heal and repair the joint; however, the joint may repair in a position that is not anatomically aligned leading to recurrent dislocation.Arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and improper mobility.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.As the complaint indicates, the patient experienced a sequence of events including scar tissue build up and dislocation as the result of chronic flail arm syndrome.Root cause of the reported event is not device related.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: STANDARD 40MM DIAMETER BEARING
• 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: 21928409
• Report Number: 0001822565-2025-01194
• Device Sequence Number: 9086637
• Product Code: PHX
• UDI-Device Identifier: 00887868231582
• UDI-Public: (01)00887868231582(17)290619(10)66747299
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 08/25/2025

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: Health Professional
• Device Catalogue Number: 110031427
• Device Lot Number: 66747299
• 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: 04/05/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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: Required Intervention; Hospitalization
• Patient Sex: Male