MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for PERSONA CEMENTED STEMMED TIBIAL COMPONENT SIZE E RIGHT N/A 42532007102 manufactured by Zimmer Orthopaedic Mfg. Ltd..
[188010169]
(b)(4). Concomitant medical products: persona cruciate retaining cemented femoral component size 6 right, catalog #: 42502606002, lot #: 63863881. Persona cruciate retaining articular surface 11mm right, catalog #: 42521000511, lot #: 63226721. Report source - foreign: (b)(6). The complainant has indicated that the devices will not be returned to zimmer biomet for evaluation, as the devices remain implanted. Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2020-00096, 3007963827-2020-00098.
Patient Sequence No: 1, Text Type: N, H10
[188010170]
It is reported that the patient experienced severe pain, swelling difficulty performing daily activities and noise from the knee approximately two (2) years following right knee arthroplasty. The patient is currently taking paracetamol for pain management. Attempts have been made and no additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007963827-2020-00097 |
| MDR Report Key | 9902933 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-16 |
| Date Mfgr Received | 2020-03-22 |
| Device Manufacturer Date | 2017-01-05 |
| 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 ORTHOPAEDIC MFG. LTD. |
| Manufacturer Street | BUILDING NO 2 EAST PARK SHANNON INDUSTRIAL ESTATE |
| Manufacturer City | SHANNON, COUNTY CLARE |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERSONA CEMENTED STEMMED TIBIAL COMPONENT SIZE E RIGHT |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | JWH |
| Date Received | 2020-03-31 |
| Model Number | N/A |
| Catalog Number | 42532007102 |
| Lot Number | 63549985 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER ORTHOPAEDIC MFG. LTD. |
| Manufacturer Address | BUILDING NO 2 EAST PARK SHANNON INDUSTRIAL ESTATE SHANNON, COUNTY CLARE EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-31 |