MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2018-06-18 for UNKNOWN HUMERAL TRAY N/A manufactured by Zimmer Biomet, Inc..
[111399972]
(b)(4). Concomitant medical products: 211260, compr srs mod stem - 9 x 150 mm, 878780. Unknown, unknown glenoshpere, unknown. The 211218, compr srs prox bdy - lg 42 mm, 258120. Unknown, unknown humeral bearing, unknown. Unknown, unknown baseplate, unknown. Unknown, unknown central screw, unknown. Unknown, unknown peripheral screw, unknown. (b)(6). 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 part and lot numbers of the device involved in the event 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. This report is being submitted late as it has been identified in remediation. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01437, 0001825034-2018-04090, 0001825034-2018-01436, 0001825034-2018-04092, 0001825034-2018-04093, 0001825034-2018-04094, 0001825034-2018-04095.
Patient Sequence No: 1, Text Type: N, H10
[111399973]
It was reported that the patient underwent a right shoulder surgery due to a neck fracture. Patient underwent a surgery for debridement due to infection and septic loosening. As part of this study, the patient underwent a right shoulder revision procedure. It was reported that the patient suffered dislocation and subluxation of the prosthesis. The patient underwent hematoma evacuation and implant reduction as part of treatment. Subsequently, during a six month, one year, and three year follow-up, the patient reported being unable to open a jar, difficulty with heavy chores and recreational activities, washing back, and difficulty carrying bag and using a knife. The shoulder has caused moderately limited social life and work. Patient also noted for all three follow ups that there was no arm, shoulder, or hand pain. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-04091 |
| MDR Report Key | 7611522 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2018-06-18 |
| Date of Report | 2018-06-18 |
| Date of Event | 2014-09-09 |
| Date Mfgr Received | 2014-10-27 |
| Date Added to Maude | 2018-06-18 |
| 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 HUMERAL TRAY |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | MJT |
| Date Received | 2018-06-18 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | N/A |
| Operator | PHYSICIAN |
| 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. Other | 2018-06-18 |