UNKNOWN CUP
Report
- Report Number
- 0001822565-2025-02406
- Event Type
- Injury
- Date Received
- July 8, 2025
- Date of Event
- June 18, 2024
- Report Date
- April 9, 2026
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JDI
- PMA / PMN Number
- NA
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). B3: EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. G2: BECKERS G, MORCOS MW, LAVIGNE M, MASSÉ V, KISS MO, VENDITTOLI PA. EXCELLENT RESULTS OF LARGE-DIAMETER CERAMIC-ON-CERAMIC BEARINGS IN TOTAL HIP ARTHROPLASTY AT MINIMUM TEN-YEAR FOLLOW-UP. J ARTHROPLASTY. 2024 DEC;39(12):3028-3035. DOI: 10.1016/J.ARTH.2024.06.045. EPUB 2024 JUN 22. PMID: 38909852. G3: CANADA. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H6. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. FURTHERMORE, HETEROTOPIC OSSIFICATION (HO) IS THE ABNORMAL AND RAPID GROWTH OF BONE THAT FORMS WITHIN SOFT TISSUE AS THE RESULT OF HEREDITY, TRAUMA, SURGICAL HISTORY, OR DISEASES OF A JOINT. THE RAPID AND IRREGULAR GROWTH OF BONE OFTEN CAUSES A SHARP OR JUTTED STRUCTURE TO FORM, WHICH CAN RESULT IN PAIN AND IRRITATION TO THE SURROUNDING TISSUES, OR THE PATIENT CAN REMAIN ASYMPTOMATIC. RADIATION OR NONSTEROIDAL ANTI-INFLAMMATORY MEDICATIONS ARE OFTEN PROVIDED TO PREVENT HO FORMATION. THE ONLY TREATMENT, IF NECESSARY, IS SURGICAL EXCISION OR SHAVING/SMOOTHING OUT THE EXCESS BONE. AS TIMEFRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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 TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D2, G1, G3, G6, H1, H2, H11. H1: THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE LITERATURE MDR REPORTING REVIEW AND REMEDIATION EFFORT BASED ON MDR REPORTING PROCESS AND FDA ADVERSE EVENT REPORTING REQUIREMENT. CAPA -07984 WAS OPENED ON (B)(6) 2026 TO ADDRESS CORRECTIONS. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THE REPORTED EVENT WAS IDENTIFIED DURING REVIEW OF A JOURNAL ARTICLE. BECKERS ET AL LITERATURE REVIEW. TITLE: EXCELLENT RESULTS OF LARGE-DIAMETER CERAMIC-ON-CERAMIC BEARINGS IN TOTAL HIP. THE STUDY REPORTED 6 (SIX) PATIENTS DISPLAYED ACETABULAR HETEROTOPIC OSSIFICATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297582 | UNKNOWN CUP | PROSTHESIS, HIP | JDI | ZIMMER BIOMET, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | UNKNOWN HEAD.UNKNOWN LINER.UNKNOWN STEM. |