MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-25 for ALL POLY PATELLA CEMENTED 35 MM DIAMETER N/A 42540000035 manufactured by Zimmer Manufacturing B.v..
[185936791]
(b)(4). Concomitant medical products: 00599601451 - femoral component - 64160648, 00599600312 - lps all poly tib - 64253704. Procedural related complications are influenced by the 'type of surgery, patients pre-existing comorbid state, and perioperative management. ' low o2/oxygen levels in the blood stream is a known post-operative complication due to administration of anesthesia during the procedure. If the complication occurs, this should resolve within 24-48 hours? Postoperative. Low o2/oxygen levels can also be impacted by the administration of narcotics during the post recovery phase. Narcotic side effects decrease patient? S alertness and breathing rate, causing the patient to have shallow breathing impacting the amount of oxygen being supplied to the body. Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00095. 0001822565-2020-01106.
Patient Sequence No: 1, Text Type: N, H10
[185936792]
It was reported that the patient underwent an initial total left knee arthroplasty. During the initial hospital stay, it was reported the patient experienced low oxygen saturation leading to prolonged hospitalization for treatment. The patient was sent home on oxygen therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2020-00206 |
| MDR Report Key | 9880024 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2018-06-27 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| Model Number | N/A |
| Catalog Number | 42540000035 |
| Lot Number | 64087383 |
| 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. Hospitalization; 2. Other | 2020-03-25 |