ACT ARTIC E1 HIP BRG 28X46MM
Report
- Report Number
- 0001825034-2022-01793
- Event Type
- Injury
- Date Received
- August 4, 2022
- Date of Event
- July 11, 2022
- Report Date
- November 7, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- UDI-DI
- 00880304485068
- PMA / PMN Number
- K161190
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CAT# 650-1055 LOT# 2886422 DELTA CERAMIC OPTION HEAD, CAT# 650-1067 LOT# 2900844 CER OPTION TYPE 1 TPR SLEVE, CAT# EP-200152 LOT# 038300 ACT ARTIC E1 HIP BRG 28X46MM S52 DIA28. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. ONE G7 DUAL MOBILITY LINER 46MM G, DELTA CERAMIC OPTION HEAD DIA2 8, CER OPTION TYPE 1 TPR SLEVE +3 PE 1, AND ACT ARTIC E1 HIP BRG 28X46MM S52 DIA28 WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE CERAMIC HEAD HAD WEAR TO THE OUTER RADIUS. THE RETURNED LINER HAD LIP DAMAGE AND SCUFFING ON THE INNER RADIUS. THE TAPER HAS LIP DAMAGE. THE POLY LINER HAS LIP DAMAGE AND INDENTATIONS ON THE OUTSIDE RADIUS. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: SUPERIOR DISLOCATION OF THE FEMORAL COMPONENT WITH RESPECT TO THE CUP, ECCENTRIC POSITIONING OF THE FEMORAL HEAD COMPONENT WITHIN THE CUP. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: A4, B4, B5, B7, D1, D2, D4, G3, G4, H2, H3, H6.
IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO A DISLOCATION. THE HEAD AND LINER WERE REPLACED. NO ADDITIONAL INFORMATION.
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.
IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO DISLOCATION, PAIN, LEG LENGTH DISCREPANCY AND DISSOCIATION. DURING THE REVISION THE POLYETHYLENE WAS IN THE POSTERIOR SOFT TISSUES COMPLETELY DISSOCIATED FROM THE INNER CERAMIC HEAD AND ONCE HEAD REMOVED NOTED MINIMAL TRUNNIONOSIS. THE ACETABULAR LINER AND HEAD WERE EXCHANGED WITHOUT COMPLICATIONS. NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1277111 | ACT ARTIC E1 HIP BRG 28X46MM | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | N/A | 038300 | 00880304485068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Hospitalization| R | SEE H10 NARRATIVE |