MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2018-03-29 for UNKNOWN BIOLOX HEAD N/A manufactured by Zimmer Gmbh.
[103796178]
Concomitant medical product: unknown alloclassic cup, ref# unknown, lot# unknown. The following report is associated with this event: 0009613350-2018-00405. The manufacturer did not receive the device for investigation. No surgical report or x-rays were provided for review. As no lot numbers were provided for the devices, the device history records could not be reviewed. Additional information has been requested and is currently not available. A cause for this specific event cannot be ascertained from the information provided. As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted. Note: this is a split case with zimmer inc. , (b)(4) reference number (b)(4). Zimmer's reference number of this file is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103796179]
It was reported that the patient underwent initial hip arthroplasty on an unknown date. Subsequently, the patient was revised on an unknown date due to unknown reason.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2018-00406 |
| MDR Report Key | 7380975 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2018-03-29 |
| Date of Report | 2018-09-12 |
| Date of Event | 2015-10-01 |
| Date Mfgr Received | 2018-09-10 |
| Device Manufacturer Date | 2015-03-23 |
| Date Added to Maude | 2018-03-29 |
| 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 GMBH |
| Manufacturer Street | SULZER ALLEE 8 SULZER INDUSTRIE PARK |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN BIOLOX HEAD |
| Generic Name | UNKNOWN |
| Product Code | OQI |
| Date Received | 2018-03-29 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-03-29 |