UNKNOWN OXFORD FEMORAL COMPONENT
Report
- Report Number
- 3002806535-2021-00375
- Event Type
- Injury
- Date Received
- September 2, 2021
- Date of Event
- August 24, 2021
- Report Date
- November 26, 2021
- Manufacturer
- BIOMET UK LTD.
- Product Code
- NRA
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED: MEDICAL RECORDS RECEIVED: PATIENT'S YEAR OF BIRTH: 1949, GENDER: MALE. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY A CORRECTION TOGETHER WITH ADDITIONAL INFORMATION. WE HAVE RECEIVED FURTHER INFORMATION THAT THE PATIENT UNDERWENT REVISION SURGERY DATE: (B)(6) 2021. IT HAS BEEN CONFIRMED THAT THE PATIENT WAS SEEN IN NÆSTVED AMBULATORY REGARDING THE FRACTURED PROSTHESIS, BUT AFTER THE CONSULTATION, THE PATIENT WAS REFERRED TO BISPEBJERG HOSPITAL, WHERE THE REVISION SURGERY WAS PERFORMED BY DR. BENT OLSEN. REVISION SURGEON: (B)(6). REVISION SURGERY HOSPITAL NAME : (B)(6) HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED: FEMORAL ITEM NUMBER: 154602. BEARING ITEM NUMBER: 159583. TIB TRAY ITEM NUMBER: 154776. NO LOT NUMBERS CAN BE IDENTIFIED ON THESE ITEMS. D10 ASSOCIATED PRODUCTS: MEDICAL PRODUCT: OXF UNI TIB TRAY SZ F RM PMA. CATALOG NO.: 154776. LOT NO.: UNKNOWN. MEDICAL PRODUCT: OXF ANAT BRG RT LG SIZE 4 PMA. CATALOG NO.: 159583. LOT NO.: UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: IT WAS REPORTED THAT: THE PATIENT HAD AN OXFORD PARTIAL KNEE IN 2008. SUBSEQUENTLY, THE PATIENT HEARD A SNAP IN THE KNEE AND AFTERWARDS EXPERIENCED PAIN. THE X-RAYS SHOW THAT THE FEMORAL COMPONENT IS BROKEN IN TWO. REVISION SURGERY IS PLANNED FOR THE (B)(6) 2021. PRODUCTS WERE RETURNED TO BIOMET UK FOR INVESTIGATION, AND FORWARDED TO THE RESEARCH ENGINEER FOR EVALUATION. AN OXFORD PARTIAL KNEE FEMORAL COMPONENT, MENISCAL BEARING AND TIBIAL TRAY HAVE BEEN REVISED AFTER APPROXIMATELY 13 YEARS DUE TO FRACTURE OF THE FEMORAL COMPONENT. THE FEMORAL COMPONENT HAD FRACTURED INTO TWO FRAGMENTS. THE CEMENT MANTLE APPEARED UNEVEN AND THERE WAS A GAP PRESENT BETWEEN THE CEMENT MANTLE AND THE COMPONENT ON BOTH FRAGMENTS. VISUAL EXAMINATION OF THE FRACTURE SURFACES ALSO SHOWED THE PRESENCE OF BEACH MARKS INDICATING THAT FATIGUE MAY HAVE CONTRIBUTED TO THE FAILURE. EXTENSIVE WEAR OF THE POLYETHYLENE WAS OBSERVED, WHICH MAY HAVE BEEN CAUSED BY IMPINGEMENT AND/OR CONTACT WITH THE FRACTURED FEMORAL COMPONENT. THE INFERIOR BEARING SURFACE SHOWED SCRATCHES IN THE DIRECTION OF ARTICULATION, WHICH INDICATES THAT THIRD BODY WEAR MAY ALSO HAVE BEEN A CONTRIBUTING FACTOR TO THE HIGHER THAN EXPECTED WEAR RATE. IMMEDIATE POST-PRIMARY RADIOGRAPHS, SURGICAL NOTES AND PATIENT INFORMATION HAVE NOT BEEN PROVIDED AND ARE REQUIRED TO DETERMINE THE PRIMARY REASON OF THE FEMORAL COMPONENT FRACTURE. THE DEFINITIVE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION, HOWEVER SUBOPTIMAL CEMENTING TECHNIQUE, IMPINGEMENT AND REPEAT EXPOSURE TO ELEVATED STRESSES MAY HAVE BEEN CONTRIBUTING FACTORS. A REVIEW OF THE COMPLAINTS DATABASE SHOWS THAT WE HAVE RECEIVED NO REPORTED EVENTS FOR " REVISION DUE TO IMPLANT FRACTURE" FOR THE SAME ITEM NUMBER PRIOR TO THE REPORTED EVENT. THE SEVERITY OF THE REPORTED EVENT FOR SIMILAR COMPLAINTS ARE IN LINE WITH THE RISK FILE. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. INVESTIGATION IS COMPLETED BASED ON CURRENT AVAILABLE INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED.
IT WAS REPORTED THAT THE PATIENT HAD AN OXFORD PARTIAL KNEE IN 2008. SUBSEQUENTLY, 2 MONTHS AGO THE PATIENT HEARD A SNAP IN THE KNEE AND AFTERWARDS EXPERIENCED PAIN. THE X-RAYS SHOW THAT THE FEMORAL COMPONENT IS BROKEN IN TWO. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.
IT WAS REPORTED THAT THE PATIENT HAD AN OXFORD PARTIAL KNEE IN 2008. SUBSEQUENTLY, 2 MONTHS AGO THE PATIENT HEARD A SNAP IN THE KNEE AND AFTERWARDS EXPERIENCED PAIN. THE X-RAYS SHOW THAT THE FEMORAL COMPONENT IS BROKEN IN TWO. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.
IT WAS REPORTED THAT THE PATIENT HAD AN OXFORD PARTIAL KNEE IN 2008. SUBSEQUENTLY, 2 MONTHS AGO THE PATIENT HEARD A SNAP IN THE KNEE AND AFTERWARDS EXPERIENCED PAIN. THE X-RAYS SHOW THAT THE FEMORAL COMPONENT IS BROKEN IN TWO. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.
IT WAS REPORTED THAT THE PATIENT HAD AN OXFORD PARTIAL KNEE IN 2008. SUBSEQUENTLY, 2 MONTHS AGO THE PATIENT HEARD A SNAP IN THE KNEE AND AFTERWARDS EXPERIENCED PAIN. THE X-RAYS SHOW THAT THE FEMORAL COMPONENT IS BROKEN IN TWO. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.
(B)(4). INITIAL REPORT: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(4). REVISION SURGERY IS SCHEDULED FOR THE (B)(6) 2021. WE EXPECT THE PRODUCT TO BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION IN DUE COURSE. ASSOCIATED PRODUCTS: MEDICAL PRODUCT: UNK OXFORD TIBIAL COMPONENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MEDICAL PRODUCT: UNK OXFORD BEARING, CATALOG #: UNKNOWN, LOT #: UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT REMAINS IMPLANTED.
IT WAS REPORTED THAT THE PATIENT HAD AN OXFORD PARTIAL KNEE IN 2008. SUBSEQUENTLY, 2 MONTHS AGO THE PATIENT HEARD A SNAP IN THE KNEE AND AFTERWARDS EXPERIENCED PAIN. THE X-RAYS SHOW THAT THE FEMORAL COMPONENT IS BROKEN IN TWO. REVISION SURGERY IS PLANNED FOR THE (B)(6) 2021. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1314562 | UNKNOWN OXFORD FEMORAL COMPONENT | OXFORD PARTIAL KNEE SYSTEM | NRA | BIOMET UK LTD. | N/A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Hospitalization| R |