MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-01-31 for COCR FEMORAL HEAD NI 00801803602 manufactured by Zimmer Manufacturing B.v..
[177193714]
(b)(4). Concomitant medical products: liner standard 3. 5 mm cat# 00630505036 lot# 61281052, modular neck k 12/14 neck taper cat# 00784800200 lot# 61045351, tm shell cat# 00620205022 lot# 61273459, screw cat# 00625006530 lot# 61277468, stem cat# 00771300700 lot# 61068324. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2020 -00047, 0001822565 -2020 -00402.
Patient Sequence No: 1, Text Type: N, H10
[177193715]
It was reported that a patient had an initial left total hip arthroplasty performed. Subsequently, the patient was revised approximately 10 years later due to pain, bursitis, tendon tear, and elevated metal ions. During the revision surgery, no tissue reaction was found but minimal head and neck taper corrosion was noted. The head, neck, liner, and locking ring were replaced without complication, and the torn tendon was repaired. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2020-00048 |
| MDR Report Key | 9653024 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2009-06-17 |
| Date Added to Maude | 2020-01-31 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COCR FEMORAL HEAD |
| Generic Name | PROSTHESIS, HIP |
| Product Code | JDL |
| Date Received | 2020-01-31 |
| Model Number | NI |
| Catalog Number | 00801803602 |
| Lot Number | 61269403 |
| Device Expiration Date | 2019-06-15 |
| 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 | 2020-01-31 |