MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,health p report with the FDA on 2020-03-31 for PALACOS R 1X40 SINGLE N/A 00111214001 manufactured by Zimmer Biomet, Inc..
[186666760]
(b)(4). Concomitant medical products: 42532007102 - tibia cemented 5 degree stemmed right size e - 63776398, 42540000032 - all poly patella cemented 32 mm diameter - 63940183, 42500006002 - femur cemented posterior stabilized (ps) - 63819645, 42521400710 - articular surface fixed bearing posterior stabilized (ps) - 63844848. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown. 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: 0001822565-2020-01200.
Patient Sequence No: 1, Text Type: N, H10
[186666761]
It was reported that the patient underwent a right knee revision approximately 19 months post implantation due to pain and loosening at the cement interface. It was also noted the patient suffered from a hairline fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-01201 |
| MDR Report Key | 9904360 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-10-28 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-31 |
| 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 R 1X40 SINGLE |
| Generic Name | BONE CEMENT |
| Product Code | LOD |
| Date Received | 2020-03-31 |
| Model Number | N/A |
| Catalog Number | 00111214001 |
| Lot Number | 87524706 |
| 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 | 2020-03-31 |