MAG TPR ADPR TI 38-40/-2 12/14
Report
- Report Number
- 3002806535-2018-01271
- Event Type
- Injury
- Date Received
- December 13, 2018
- Date of Event
- November 22, 2018
- Report Date
- May 19, 2021
- Manufacturer
- BIOMET UK LTD.
- Product Code
- KWA
- PMA / PMN Number
- K042037
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PREVIOUS REPORT 3002806535-2018-01271-2 WAS CREATED AND SUBMITTED IN ERROR. PLEASE IGNORE.
(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10. COMPLAINT SUMMARY: AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. SIX ANTEROPOSTERIOR (AP) X-RAYS WERE PROVIDED FOR ANALYSIS WITH (B)(4): ONE FULL-PELVIS X-RAY AND ANOTHER X-RAY IN ABDUCTION AND EXTERNAL ROTATION (DATED (B)(6) 2019, PRE-PRIMARY SURGERY); ONE FULL-PELVIS X-RAY AND ANOTHER X-RAY IN ABDUCTION AND EXTERNAL ROTATION (DATED (B)(6) 2019, POSTPRIMARY SURGERY); ONE FULL-PELVIS X-RAY AND ANOTHER X-RAY IN ABDUCTION AND EXTERNAL ROTATION (DATED (B)(6) 2020, POST-REVISION SURGERY). ONLY THE TWO POST-PRIMARY X-RAYS (TAKEN ON (B)(6) 2019) WERE CONSIDERED IN THIS ASSESSMENT. THE INCLINATION ANGLE OF THE G7 BISPHERICAL SHELL WAS MEASURED TO BE 34.5° IN THE AP X-RAY TAKEN ON (B)(6) 2019, WHICH IS LOWER THAN THE RECOMMENDED SURGICAL INCLINATION ANGLE IN THE G7 BISPHERICAL SURGICAL TECHNIQUE. THE PREFERRED ACETABULAR ORIENTATION IS 40 DEGREES INCLINATION AND 20 DEGREES OF ANTEVERSION(¿) THE ZIMMER BIOMET PRODUCT EXPERIENCE REPORT (ZPER) MENTIONS THAT THE PATIENT IS FEMALE, WAS 65 YEARS OLD AT THE TIME OF THE EVENT, WEIGHED 44 KG AND WAS 1.51 M TALL, THUS HAVING A BMI OF 19.3 (NORMAL WEIGHT). THE ZPER ALSO STATES THAT THE SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILISED, AND THAT THERE WERE NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. THE MEDICAL RECORD REVIEW FORM MENTIONS THAT THE ONSET DATE OF THE ADVERSE EVENT WAS (B)(6) 2020. THE ADVERSE EVENT CONSISTED OF SUBLUXATION AT 130 DEGREES, NAMELY MULTIPLE SUBLUXATIONS IN MAXIMUM FLEXION POSITION OF THE RIGHT HIP JOINT. IT STATES THAT THE PRIMARY PROCEDURE OCCURRED WITHOUT COMPLICATION. DURING REVISION SURGERY ON (B)(6) 2020, THE G7 BISPHERICAL SHELL AND G7 E1 LINER WERE REVISED AND REPLACED WITH A G7 OSSEOTI 48 MM CUP, A DUAL MOBILITY 38/C LINER, AND A DUAL MOBILITY 38/C BEARING. THE BIOLOX DELTA 28 FEMORAL HEAD AND GTS -4 STEM WERE NOT REVISED. THE USE OF A DUAL MOBILITY DEVICE SUGGESTS THAT THE PATIENT WAS AT RISK OF FURTHER SUBLUXATION. A TRANSLATION OF THE SURGICAL NOTES FROM THE PRIMARY SURGERY ON (B)(6) 2019 WAS PROVIDED WITH (B)(4). IT IS STATED THAT THE SURGEON PERFORMED REDUCTION OF THE JOINT AND FINAL FUNCTIONAL EXAMINATION WITH PROOF OF PERFECT MOBILITY WITHOUT LUXATION TENDENCY OR IMPINGEMENT. A TRANSLATION OF THE SURGICAL NOTES FROM THE REVISION SURGERY ON (B)(6) 2020 WAS ALSO PROVIDED WITH (B)(4). IT IS STATED THAT AFTER MULTIPLE SUBLUXATIONS IN MAXIMUM FLEXION POSITION OF THE RIGHT JOINT, THE PATIENT IS INSECURE AND LIVES IN FEAR OF FURTHER PAINFUL SUBLUXATIONS, WHICH SUGGESTS THAT THE PATIENT DOES REGULAR PHYSICAL ACTIVITY. THE NOTES CONFIRM THE EXISTENCE OF STRONG SCARRING IN THE FASCIA, NAMELY TOTALLY FIBROSED AND SCARRED NEOCAPSULE. REGARDING JOINT LAXITY, THE NOTES MENTION THAT DURING THE FUNCTIONAL EXAMINATION, THE SUBLUXATION DESCRIBED IN THE OPERATION CAN BE REPRODUCED AT APPROXIMATELY 130° OF FLEXION. THERE IS A TYPICAL SITUATION: WITH STRONG FLEXION OF THE HOOF, THE NECK OF THE FEMUR ACTS AS A LEVER AT THE VENTRAL EDGE OF THE GLENOID CAVITY. THE MANUFACTURING HISTORY RECORDS (MHRS) FOR THE G7 BISPHERICAL ACETABULAR SHELL AND THE BIOLOX DELTA FEMORAL HEAD HAVE BEEN CHECKED AND VERIFY THAT THE COMPONENTS WERE MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. THE G7 E1 LINER IS NOT UK DESIGN CONTROL, AND THEREFORE ITS MHR WAS MADE AVAILABLE IN LINKED COMPLAINT (B)(4). ITS MHR HAS BEEN CHECKED AND VERIFIES THAT THE COMPONENT WAS MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. THE CAUSE OF THE SUBLUXATION CANNOT BE DETERMINED WITH CERTAINTY AT THE TIME OF WRITING, BUT IT IS POSSIBLE THAT THE LOW INCLINATION ANGLE OF THE ACETABULAR COMPONENT, SOFT TISSUE LAXITY AND THE PATIENT¿S ACTIVITY LEVEL MAY HAVE BEEN CONTRIBUTING FACTORS. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 1 COMPLAINT REPORTED WITH THE ITEM 650-0831 AND 110017328 EACH (INCLUDING INITIATING COMPLAINT). WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2021-00057-2 IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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 FOR TRENDS.
PREVIOUS REPORT SUBMITTED IN ERROR.
THE PATIENT RECEIVED AN INITIAL RIGHT THA ON (B)(6) 2019. THE PATIENT EXPERIENCED MULTIPLE DISLOCATIONS AND WAS REVISED ON (B)(6) 2020 DUE TO SUBLUXATION AND SCAR TISSUE WAS NOTED DURING REVISION.
IT WAS REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT SURGERY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED, DUE TO METALLOSIS.
(B)(4). CONCOMITANT MEDICAL PRODUCT - M2A-MAGNUM MOD HD SZ 40MM, ITEM 157440, LOT 1120212; THERAPY DATE - (B)(6) 2018. CONCOMITANT MEDICAL PRODUCT - M2A-MAGNUM RECAP CUP 46ODX40ID ,ITEM 157846, LOT 817398; THERAPY DATE - (B)(6) 2018. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-01269 AND 3002806535-2018-01270.
REVISION DUE TO METALLOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1002449 | MAG TPR ADPR TI 38-40/-2 12/14 | HIP PROSTHESIS | KWA | BIOMET UK LTD. | 1112455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | SEE H10 |