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 2019-10-15 for PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIAL N/A 42538000502 manufactured by Zimmer Orthopaedic Mfg. Ltd..
[162429573]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Age or dob: (b)(6). Concomitant medical products: 42558000402, partial femur cemented, lot # 63532896. 42528200508, partial articular surface, lot # 63583930. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04430, 0001822565 - 2019 - 04431.
Patient Sequence No: 1, Text Type: N, H10
[162429574]
It was reported that approximately 1 year post implantation, the patient was treated for pain and instability. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007963827-2019-00295 |
| MDR Report Key | 9193093 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-15 |
| Date of Report | 2019-10-31 |
| Date of Event | 2019-04-30 |
| Date Mfgr Received | 2019-10-16 |
| Device Manufacturer Date | 2018-02-02 |
| Date Added to Maude | 2019-10-15 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIAL |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | HSX |
| Date Received | 2019-10-15 |
| Model Number | N/A |
| Catalog Number | 42538000502 |
| Lot Number | 63881381 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2019-10-15 |