TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE G
Report
- Report Number
- 0001822565-2024-01218
- Event Type
- Injury
- Date Received
- April 11, 2024
- Date of Event
- April 2, 2024
- Report Date
- October 24, 2024
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- MBH
- UDI-DI
- 00889024510593
- PMA / PMN Number
- K173417
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). G2- SWITZERLAND. H3- CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10- MEDICAL PRODUCT: UNK PERSONA FEMUR CR TM 11 NARROW, UNK INLAY F UC 10MM. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, D2, D4, D10, G1, G3, G6, H1, H2, H4, AND H11. D10-MEDICAL PRODUCT: UNK PERSONA FEMUR CR TM 11 NARROW. ARTICULAR SURFACE FIXED BEARING (UC) LEFT 10 MM HEIGHT; ITEM# 42511200610; LOT# 65625577 I. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, D2, G1, G3, G6, H1, H2, H3, H6, AND H11. A HEMATOMA IS A MASS OF CLOTTED BLOOD THAT FORMS IN A TISSUE, ORGAN, OR BODY SPACE. A HEMATOMA CAN BE ASSOCIATED WITH PAIN, SWELLING, ECCHYMOSIS, SEROSANGUINOUS OR BLOODY DRAINAGE AFTER A RECENT SURGICAL PROCEDURE OR TRAUMA AND CAN PREDISPOSE THE PATIENT TO INFECTION. THE DEVELOPMENT OF A POSTOPERATIVE HEMATOMA CAN BE CORRELATED WITH THE SURGICAL PROCEDURE AND PERIOPERATIVE ANTICOAGULATION THERAPY PRESCRIBED TO PREVENT THROMBUS FORMATION. MOST HEMATOMAS RESOLVE ON THEIR OWN, WITHOUT SURGICAL INTERVENTION, WHILE SOME DO NOT. LARGER HEMATOMAS MAY NEED TO BE SURGICALLY EVACUATED IN ORDER TO RESOLVE. AS TIMEFRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED. MEDICAL RECORDS WERE NOT PROVIDED FOR THE REVISION PROCEDURE. RADIOGRAPHS WERE PROVIDED. IMAGES WERE NOT SENT TO MMI AS THEY ARE POST-REVISION X-RAYS, WHICH WOULD NOT ENHANCE THE INVESTIGATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, D2, D9, G1, G3, G6, H1, H2, H3, H6, AND H11. CORRECTED: H4. VISUAL EXAMINATION OF THE RETURNED TIBIA FOUND SIGNS OF BEING IMPLANTED WITH THE PRESENCE OF SURGICAL DEBRIS. THE TIBIA EXHIBITS DAMAGE (NICKED / GOUGED / WEAR) WITH ONE OF THE POSTS BEING FRACTURED FROM THE BASE OF THE TIBIA PLATE. ADDITIONAL TESTING WAS PERFORMED ON THE FRACTURED TIBIA, WHICH COULD NOT DETERMINE THE MODE OF FAILURE; HOWEVER, CUSTOMER FEEDBACK WAS LATER RECEIVED AND FOUND DEVICE TO HAVE FRACTURED DURING EXPLANTATION. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: REVISION DUE TO UNKNOWN REASONS; HEMATOMA IDENTIFIED DURING REVISION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT A PATIENT'S TIBIAL COMPONENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.
IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TEN AND A HALF MONTHS POST IMPLANTATION DUE TO UNKNOWN REASONS. A HEMATOMA WAS IDENTIFIED UPON REVISION. A NEW TIBIAL COMPONENT WAS CEMENTED IN PLACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 641648 | TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE G | PROSTHESIS, KNEE | MBH | ZIMMER BIOMET, INC. | N/A | 65503221 | 00889024510593 |
| 751968 | TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE G | PROSTHESIS, KNEE | MBH | ZIMMER BIOMET, INC. | N/A | 65503221 | 00889024510593 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention| H | SEE H10.| SEE H11. |