MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-01-23 for PARTIAL TIBIAL CEMENTED SIZE F LEFT MEDIAL N/A 42538000601 manufactured by Zimmer Orthopaedic Mfg. Ltd..
[176085909]
(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. Report source: event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[176085910]
It was reported that approximately 1 month post implantation, the patient experienced pain and was found to have a tibial bone fracture. The patient has indicated a possible revision, but one has not been confirmed yet. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007963827-2020-00033 |
| MDR Report Key | 9622805 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-01-23 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2019-04-18 |
| Date Added to Maude | 2020-01-23 |
| 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 F LEFT MEDIAL |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | HSX |
| Date Received | 2020-01-23 |
| Model Number | N/A |
| Catalog Number | 42538000601 |
| Lot Number | 64271273 |
| 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. Other | 2020-01-23 |