REVITAN®, DISTAL PART, STRAIGHT, UNCEMENTED, 20/260
Report
- Report Number
- 0009613350-2022-00109
- Event Type
- Injury
- Date Received
- February 25, 2022
- Date of Event
- January 26, 2022
- Report Date
- July 21, 2022
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- LZO
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. X-RAYS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. X-RAYS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
ADDITIONAL INFORMATION RECEIVED ON FEB 15, 2022: NEW INFORMATION RECEIVED: - EVENT UPDATED / CHANGE. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF INITIAL MEDWATCH. CORRECTED AND ADDITIONAL INFORMATION IS FILLED IN THE FOLLWING FIELDS: ADDITIONAL AND CORRECTION: B5; G3; H1; H2; H6; H10. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING, A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2022-00156. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION, THE TAPER CONNECTION BETWEEN THE CONNECTION PIN AND THE PROXIMAL PART OF THE REVITAN STEM BECAME LOOSE. THE REASON FOR THIS LOOSENING IS UNKNOWN AND NO COMMENTS CAN BE MADE AT WHAT POINT IN TIME THE TAPER CONNECTION BECAME LOOSE. BECAUSE OF THE LOOSENING OF THE TAPER CONNECTION THE PROXIMAL PART WAS ABLE TO MOVE AGAINST THE CONNECTION PIN. THE CONNECTION PIN¿S REPETITIVE CONTACT WITH THE PROXIMAL PART AFTER THE LOOSENING LED TO WEAR ON THE INNER DIAMETER OF THE PROXIMAL PART, AND MOST LIKELY ALSO CAUSED DAMAGE TO THE CONNECTION PIN. AS A CONSEQUENCE OF THE WEAR, THE PROXIMAL PART WAS ABLE TO TIP MEDIALLY. ONE UNLABELLED CT IMAGE WAS PROVIDED OF LOW IMAGE QUALITY FOR THE BONE STRUCTURE DUE TO LIMITED RESOLUTION AND IMAGE ARTIFACTS. AS THERE IS NO CLINICAL INFORMATION AVAILABLE (E.G. PATIENT MEDICAL HISTORY, OR A COMPLETE X-RAY FOLLOW-UP TO ASSESS ANY POTENTIAL BONE CHANGES AND LOOSENING OF THE PROXIMAL PART OVER TIME) THE BACKGROUND OF THIS CASE REMAINS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES ARE USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE.
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE.
IT WAS REPORTED THAT THERE WAS A REVISION DUE TO LOOSENING/DISASSEMBLING OF THE STEM. THERE WAS NO CONE FRACTURE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2358896 | REVITAN®, DISTAL PART, STRAIGHT, UNCEMENTED, 20/260 | N/A | LZO | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | 2290058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Hospitalization| R |