MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-03-27 for PALACOS RG 1X40 SINGLE N/A 00111314001 manufactured by Zimmer Biomet, Inc..
[186169238]
Zimmer biomet complaint number (b)(4). Concomitant medical products: articular surface fixed bearing; p/n: 42511200416 , l/n: 62632159, femur cemented; p/n: 42502605801, l/n: 63702261, tibia cemented; p/n: 42532006701, l/n: 63683014, all poly patella cemented; p/n: 42540000032, l/n: 63764251, palacos rg 1x40 single; p/n: 00111314001, l/n: 85714575l16. Reported event was confirmed by review of medical records. Medical records were provided and reviewed by a health care professional. Review of the available records identified no complications during the removal of antibiotic spacers and implantation of persona primary components. No evidence of infection was noted. Review of the records from the revision surgery identified the patient was experiencing increasing pain in the latera tibial plateau and severe pain with ambulation. Osteolysis was noted on the lateral tibial plateau. Extensive scar tissue was excised. The femoral component was noted to be loose and it was identified that cement had adhered to the femoral and tibial components but not to the bone. No wear was noted on the articular surface and no signs of infection were present. The patella was not revised. Dhr was reviewed and no discrepancies were found. Per the persona knee system package insert, pain, loosening, and osteolysis are known potential adverse effects of this procedure. Root cause was unable to be determined. A summary of the investigation has been sent to the complainant. 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. Multiple mdr reports were filed for this event, please see associated reports: 3007963827 - 2020 - 00008 - 1. 3007963827 - 2019 - 00281 - 2. 0001822565 - 2020 - 01126.
Patient Sequence No: 1, Text Type: N, H10
[186169239]
It was reported the patient had a revision procedure 2 years post-implantation due to osteolysis, pain and loosening. Subsequently, all components were revised expect the patella. The surgeon noted during the revision procedure that the bone cement had adhered to the femoral and tibial implants, but not the patient's bone. Further, the surgeon noted the patient had extensive scar tissue that was excised. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-01126 |
| MDR Report Key | 9889452 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2016-12-09 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALACOS RG 1X40 SINGLE |
| Generic Name | BONE CEMENT |
| Product Code | LOD |
| Date Received | 2020-03-27 |
| Model Number | N/A |
| Catalog Number | 00111314001 |
| Lot Number | 85714575 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-27 |