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 2018-03-01 for COCR FEMORAL HEAD N/A 00902603400 manufactured by Zimmer Manufacturing B.v..
[101311516]
Cmp-(b)(4). Multiple mdr reports were filed for this event. Please also see associated report(s): 0001822565-2018-00825, 0001825034-2018-00907. Concomitant medical products: unknown part/lot; femoral stem; 11-103562 univ rnglc shl 62mm/l24, lot 176070; 11-105924 arcom 32mm rngloc lnr hwall 24, lot 211880. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. A summary of the investigation has been sent to the complainant. 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.
Patient Sequence No: 1, Text Type: N, H10
[101311517]
It was reported that the patient's right hip was revised approximately 15 years post implantation due to pain. The stem was removed, and the cup was retained. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2018-00154 |
| MDR Report Key | 7307581 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-03-01 |
| Date of Report | 2018-03-07 |
| Date of Event | 2018-01-16 |
| Date Mfgr Received | 2018-02-22 |
| Device Manufacturer Date | 2003-02-21 |
| Date Added to Maude | 2018-03-01 |
| 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 | KMC |
| Date Received | 2018-03-01 |
| Model Number | N/A |
| Catalog Number | 00902603400 |
| Lot Number | 60017229 |
| ID Number | (1) 00889024270305 |
| Device Expiration Date | 2008-02-20 |
| Operator | PHYSICIAN |
| 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 | 2018-03-01 |