MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,health p report with the FDA on 2020-03-30 for FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER N/A 00801803602 manufactured by Zimmer Manufacturing B.v..
[186675342]
(b)(4). Concomitant medical products: 00771101100 femoral stem 12/14 61273064, 00875101336 liner neutral 36 mm 61303880, 00875705802 shell with multi holes 61321986, 00625006530 bone scr 61341911, 00625006535 bone scr 61341914. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01113 stem.
Patient Sequence No: 1, Text Type: N, H10
[186675343]
It was reported that the patient underwent left total hip arthroplasty and was later revised nine years later due to unknown reasons. The femoral head was exchanged. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2020-00209 |
| MDR Report Key | 9900813 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2018-09-18 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2009-12-04 |
| Date Added to Maude | 2020-03-30 |
| 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 | FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LPH |
| Date Received | 2020-03-30 |
| Model Number | N/A |
| Catalog Number | 00801803602 |
| Lot Number | 61357236 |
| Device Expiration Date | 2019-12-02 |
| 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. Required No Informationntervention | 2020-03-30 |