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 2020-03-31 for UNKNOWN STEM N/A manufactured by Zimmer Biomet, Inc..
[187360379]
(b)(4). Concomitant medical products: unknown-unknown cup-unknown, unknown-unknown liner-unknown, unknown-unknown head-unknown. Reported event was confirmed, radiographs were provided and reviewed by a health care professional. Review of the available records identified the following: incomplete positioning of the femoral stem within the femur with radiolucency along the femoral component suggesting loosening. Osteopenia was observed. No other complications were noted. No product was returned; visual and dimensional evaluations could not be performed. Part and lot identification are necessary for review of device history records, neither were provided. Complaint history review cannot be performed without product identification. A definitive root cause cannot be determined. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends. Product location unknown.
Patient Sequence No: 1, Text Type: N, H10
[187360380]
It was reported that the patient underwent a revision procedure due to loosening of the stem. During the procedure the cup and liner were revised for maintenance. 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 | 0001822565-2020-01140 |
| MDR Report Key | 9904142 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-09 |
| 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 BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN STEM |
| Generic Name | PROSTHESIS, HIP |
| Product Code | JDI |
| Date Received | 2020-03-31 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |