UNIVERSAL GLENOID - INLAY MEDIUM
Report
- Report Number
- 1220246-2025-02457
- Event Type
- Injury
- Date Received
- June 16, 2025
- Date of Event
- May 22, 2025
- Report Date
- October 13, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- PHX
- UDI-DI
- 00888867057425
- PMA / PMN Number
- K182039
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 501
Narratives
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE DOCUMENTED EVENT INFORMATION, THE LOOSENING OF THE ECLIPSE PROSTHESIS WAS MOST LIKELY THE RESULT OF ONE OR A COMBINATION OF THE FOLLOWING FACTORS: POOR INITIAL POSITIONING OF THE HUMERAL COMPONENT ¿ THE ECLIPSE PROSTHESIS WAS REPORTEDLY POORLY INSERTED DURING THE INITIAL SURGERY, WHICH LED TO HUMERAL LOOSENING OVER TIME. ¿ THIS MISALIGNMENT LIKELY CAUSED DECENTRALIZED LOADING ON THE GLENOID POLYETHYLENE (PE) INSERT, RESULTING IN UNUSUAL WEAR PATTERNS AND DELAMINATION SEPARATION OF MATERIAL LAYERS, WHICH IS A SIGN OF MECHANICAL STRESS OR FATIGUE. SECONDARY CONTRIBUTING FACTORS: ¿ MECHANICAL WEAR DUE TO IMPROPER LOAD DISTRIBUTION. ¿ MATERIAL DEGRADATION (DELAMINATION) OF THE GLENOID INSERT, POSSIBLY ACCELERATED BY THE ABNORMAL FORCES FROM THE MALPOSITIONED HUMERAL COMPONENT. DIRECTION FOR USE DFU-0181-EO ECLIPSE¿ SHOULDER PROSTHESIS. D. ADVERSE EFFECTS 3. LOOSENING OF THE IMPLANT AS A RESULT OF CHANGED CONDITIONS IN LOAD TRANSFER, RESPECTIVELY, FATIGUE WEAR OR TISSUE REACTION TO THE IMPLANT. LOOSENING IS FREQUENTLY A CONSEQUENCE OF ONE OR SEVERAL OF THE ABOVE-LISTED RISK CONDITIONS BUT CAN ALSO BE CAUSED BY INADEQUATE ANCHORING TECHNIQUE (SEE BELOW). 4. DISLOCATION, SUBLUXATION, OR INADEQUATE SCOPE OF MOVEMENT AS A RESULT OF FAILURE TO ACHIEVE OPTIMUM POSITIONING OF THE IMPLANT. 5. BONE FRACTURES AS A RESULT OF ONE-SIDED OVERLOAD OR WEAKENED BONE STRUCTURE. G. PRECAUTIONS 1. SURGEONS ARE ADVISED TO REVIEW THE PRODUCT-SPECIFIC SURGICAL TECHNIQUE PRIOR TO PERFORMING ANY SURGERY. ARTHREX PROVIDES DETAILED SURGICAL TECHNIQUES IN PRINT, VIDEO, AND ELECTRONIC FORMATS. THE ARTHREX WEBSITE ALSO PROVIDES DETAILED SURGICAL TECHNIQUE INFORMATION AND DEMONSTRATIONS. OR CONTACT YOUR ARTHREX REPRESENTATIVE FOR AN ONSITE DEMONSTRATION. 2. SURGEONS MUST APPLY THEIR PROFESSIONAL JUDGMENT WHEN DETERMINING THE APPROPRIATELY SIZED DEVICE BASED ON THE SPECIFIC INDICATION, PREFERRED SURGICAL TECHNIQUE, AND PATIENT HISTORY. THE COMPLAINT CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO DIRECT EVIDENCE OF THE FAILURE WAS PROVIDED FOR ANALYSIS.
IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED FROM AN ECLIPSE + UNIVERSAL GLENOID TO UNIVERS LAPEL WITH UNIVERSAL GLENOID GLENOSPHERE. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2019. THE REVISION SURGERY WAS REQUIRED DUE TO HUMERAL LOOSENING OF THE ECLIPSE PROSTHESIS. ACCORDING TO THE SURGEONS STATEMENT THE IMPLANT WAS ORIGINALLY POORLY INSERTED. DURING THE REVISION, HOWEVER, IT WAS NOTED THAT THE GLENOID PE INSERT OF THE UNIVERSAL GLENOID LOOKED UNUSUAL. THE GLENOID INSERT WAS PROBABLY SUBJECTED TO DECENTRALIZED LOADING DUE TO THE POOR POSITIONING OF THE HUMERAL COMPONENT AND THEREFORE SHOWED UNUSUAL WEAR PATTERNS. HOWEVER, IT WAS ALSO NOTICEABLE THAT A KIND OF LAYER HAD COME LOOSE ON THE GLENOID INSERT ("DELAMINATION"). THE AFFECTED DEVICES AR-9121-02, AR-9347-18, AR-9300-47 AND AR-9301-01 WERE REMOVED AND THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1008468 | UNIVERSAL GLENOID - INLAY MEDIUM | SHOULDR PROSTH, REVERSE CONFIG | PHX | ARTHREX, INC. | UNIVERSAL GLENOID - INLAY MEDIUM | UNK | 00888867057425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |