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 2020-03-31 for ENDO FEMORAL HEAD 12/14 TAPER 46 MM DIAMETER N/A 00781804600 manufactured by Zimmer Manufacturing B.v..
[187370189]
(b)(4). Implant date unknown approximately 7 years ago. Concomitant medical products: part # 00781804600, endo femoral head, lot # 61522149. Report source: (b)(6). Reported event was confirmed by review of office visit notes stating patient is experiencing pain and pseudotumor. Visual inspection of the returned device notes dark debris on conical tapers. The head taper shows a thread like pattern that coincides with the surface of the stem taper. Material analysis determined that the material of non-corrosion region the head was conforming. Dhr was reviewed and no discrepancies that would relate the reported event were noted. The root cause is unable to be determined. A report of the findings was sent to the reporter. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2019 - 00724.
Patient Sequence No: 1, Text Type: N, H10
[187370190]
It was reported that patient presented to physician approximately 7 years post implantation due to pain. The patient had a negative infection workup, and radiology scan positive for pseudotumor. During the surgery, black debris and tissue was noted around the neck of the hip stem and the stem component was able to be easily removed with only a few taps of a mallet. All components were removed and replaced. Attempts have been made and additional information is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2020-00216 |
| MDR Report Key | 9902574 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-09-12 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2010-06-14 |
| Date Added to Maude | 2020-03-31 |
| 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 | ENDO FEMORAL HEAD 12/14 TAPER 46 MM DIAMETER |
| Generic Name | PROSTHESIS, HIP |
| Product Code | JDI |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2019-10-16 |
| Model Number | N/A |
| Catalog Number | 00781804600 |
| Lot Number | 61522149 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-31 |