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 2019-10-27 for COCR FEMORAL HEAD N/A 00801803602 manufactured by Zimmer Manufacturing B.v..
[163982236]
(b)(4). Concomitant medical products: femoral stem fiber metal midcoat collarless 12/14 neck taper standard neck offset cementless size 12 standard body, pn 00784501200, ln 60428315, liner standard 3. 5 mm offset 36 mm i. D. For use with 50/52/54 mm o. D. Shells, pn 00630505036, ln 61333463, shell porous with cluster holes 52 mm, pn 00620205222, ln 61079136, bone scr 6. 5x25 self-tap, pn 00625006525, ln 61233964. Multiple mdr reports were filed for this event, please see associated reports 0001822565-2019-04580, 0001822565-2019-04576, 0001822565-2019-04578. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[163982237]
It was reported a patient had an initial left tha. Subsequently, the patient was revised approximately 9 years later due to pain, metallosis, limited mobility range of motion, tendinitis, swelling, tissue damage, heterotopic ossification, implant migration, implant fracture, pseudotumor/pseudocapsule, and osteolysis. Attempts have been made and additional information on the reported event is unavailable at this time. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2019-00770 |
| MDR Report Key | 9243432 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-10-27 |
| Date of Report | 2019-10-25 |
| Date of Event | 2018-05-10 |
| Date Mfgr Received | 2019-09-30 |
| Device Manufacturer Date | 2009-12-11 |
| Date Added to Maude | 2019-10-27 |
| 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 | COCR FEMORAL HEAD |
| Generic Name | PROSTHESIS, HIP |
| Product Code | JDL |
| Date Received | 2019-10-27 |
| Model Number | N/A |
| Catalog Number | 00801803602 |
| Lot Number | 61368537 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-10-27 |