EXC ABT RNGLC-X SHELL PC 060MM
Report
- Report Number
- 3002806535-2019-00608
- Event Type
- Injury
- Date Received
- July 24, 2019
- Date of Event
- May 13, 2019
- Report Date
- June 15, 2021
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LPH
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY A CORRECTION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, H1, H2, H10 ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH CONFIRMS THAT THE EXC ABT RNGLC-X SHELL PC 060MM, ITEM 131360, LOT 3241538 WAS NOT REMOVED DURING THE REPORTED REVISION. THE DEVICE WILL BE MOVED TO AN ASSOCIATED PRODUCT IN THE COMPLAINT.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G4, G7, H1, H2, H6, H10. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS APPROPRIATE. NORMAL BONE QUALITY ALTHOUGH THERE IS SUGGESTION OF OSTEOLYSIS INVOLVING THE PROXIMAL FEMORAL DIAPHYSIS ON THE (B)(6) 2019 STUDY. RIGHT TOTAL HIP ARTHROPLASTY WITH POSSIBLE OSTEOLYSIS INVOLVING THE PROXIMAL FEMORAL DIAPHYSIS AT THE BONE CEMENT INTERFACE OF THE TIP OF THE FEMORAL STEM. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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.
IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6), 2014. DURING THE 5 YEAR CLINICAL VISIT ON (B)(6) 2019, OSTEOLYSIS WAS FOUND DURING IMAGING. AN MRI WAS CONDUCTED ON (B)(6) 2019 WITH REPORTS OF FLUID AND CYST NEAR THE STEM. APPROXIMATELY 18 MONTHS LATER, IT WAS NOTED THAT THE OSTEOLYSIS HAS PROGRESSED AND THE STEM WAS FOUND TO BE LOOSE. THE PATIENT UNDERWENT A REVISION ON (B)(6) 2020. REVISED STEM, LINER FEMORAL HEAD, CEMENT RESTRICTOR PER AE.
IT WAS REPORTED THAT RIGHT PRIMARY THA WAS PERFORMED. DURING THE 5 YEAR CLINICAL VISIT, AN INCIDENTAL FINDING OF OSTEOLYSIS WAS REPORTED DURING IMAGING OF RIGHT HIP. NO OTHER CONCERNS REPORTED DURING THE VISIT. MRI WAS CONDUCTED WITH REPORTS OF FLUID AND CYST. NO SIGN OF MALIGNANCY OR INFECTION.
(B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: RLOC-X ARCOMXL H/W 60/36MM 26 CATALOG #: XL-053660 LOT #: 3222688. ASSOCIATED PRODUCTS- PRODUCT: SIRIUS HIP STEM 44-D CATALOG #: 51-199341 LOT #: 173010, PRODUCT: 36MM COCR MOD HD STD ITEM #: 11-363662 LOT #: 642860, PRODUCT: UNK PALACOS CEMENT ITEM #: UNKNOWN LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00609. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT RIGHT PRIMARY THA WAS PERFORMED. DURING THE 5 YEAR CLINICAL VISIT, AN INCIDENTAL FINDING OF OSTEOLYSIS WAS REPORTED DURING IMAGING OF RIGHT HIP. NO OTHER CONCERNS REPORTED DURING THE VISIT. MRI WAS CONDUCTED WITH REPORTS OF FLUID AND CYST. NO SIGN OF MALIGNANCY OR INFECTION. PATIENT WAS REFERRED FOR FURTHER EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 614489 | EXC ABT RNGLC-X SHELL PC 060MM | HIP PROSTHESIS | LPH | BIOMET UK LTD. | N/A | 3241538 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization |