MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-01-12 for UNKNOWN TRABECULAR METAL STEM N/A manufactured by Zimmer Biomet, Inc..
[97268330]
(b)(4). An additional report was submitted for this event: mfr# 0001822565-2018-0107. Concomitant medical product: trabecular metal reverse shoulder baseplate, pn: unk, ln: unk. Consumer report source - legal counsel. 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
[97268331]
It was reported that the patient underwent right shoulder surgery. Subsequently, the patient underwent a revision procedure four years later due to patient allegations of loosening.
Patient Sequence No: 1, Text Type: D, B5
[133557058]
This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Complaint history review was unable to be performed, as the part number and lot number are unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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
| Report Number | 0001822565-2018-00270 |
| MDR Report Key | 7187530 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-01-12 |
| Date of Report | 2018-03-26 |
| Date of Event | 2017-11-16 |
| Date Mfgr Received | 2018-03-26 |
| Device Manufacturer Date | 2011-11-07 |
| Date Added to Maude | 2018-01-12 |
| 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 | UNKNOWN TRABECULAR METAL STEM |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | MJT |
| Date Received | 2018-01-12 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-01-12 |