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 2019-05-31 for COMPR SRS 50MM DST HUM BDY RT N/A 110029938 manufactured by Zimmer Biomet, Inc..
[146630503]
(b)(4). Multiple mdr's were reported for this event. Please also see associated events: 0001825034-2019-00241-1. Primary di number: (b)(4). No device was returned for evaluation. Review of provided patient xrays confirm disassociation and dislocation. Review of device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event. Root cause is unknown. 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. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[146630504]
It was reported the patient was revised for a third time to address ongoing distal body disassociation from the srs im stem. The im stem was removed. No further information has been made available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-02101 |
| MDR Report Key | 8657882 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-01-09 |
| Date Mfgr Received | 2019-05-07 |
| Date Added to Maude | 2019-05-31 |
| 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 | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPR SRS 50MM DST HUM BDY RT |
| Generic Name | PROSTHESIS, EXTREMITY |
| Product Code | MBF |
| Date Received | 2019-05-31 |
| Model Number | N/A |
| Catalog Number | 110029938 |
| Lot Number | 970660 |
| 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 | 211259 | 1. Hospitalization; 2. Required No Informationntervention | 2019-05-31 |