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 2020-03-30 for ALL POLY PATELLA CEMENTED 35 MM DIAMETER N/A 42540000035 manufactured by Zimmer Manufacturing B.v..
[187575843]
(b)(4). Concomitant medical products: therapy date: unknown, 42502607001 - femur cemented - 64321215, 42532007901 - tibia cemented - 64156477, kne-unknown-bearing, 110035368 - biomet bc r 1x40 us - 824aac0510. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted. 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: 3007963827-2020-00099, 3007963827-2020-00100, 0001822565-2020-01173.
Patient Sequence No: 1, Text Type: N, H10
[187575844]
It was reported that the patient underwent left knee revision approximately one month post implantation due to instability, pain, and difficulty walking and standing. The articular surface was removed and replaced. Subsequently, the patient continues to experience the same symptoms after the revision surgery. It was also noted that the knee is discolored (dark, black) since the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2020-00215 |
| MDR Report Key | 9899254 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-07-12 |
| Date Added to Maude | 2020-03-30 |
| 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 MANUFACTURING B.V. |
| Manufacturer Street | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 |
| Manufacturer City | MERCEDITA PR 00715 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00715 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALL POLY PATELLA CEMENTED 35 MM DIAMETER |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBH |
| Date Received | 2020-03-30 |
| Model Number | N/A |
| Catalog Number | 42540000035 |
| Lot Number | 64445112 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER MANUFACTURING B.V. |
| Manufacturer Address | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 MERCEDITA PR 00715 US 00715 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-30 |