MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-06 for COMPREHENSIVE MINI PRIMARY STEM 113633 manufactured by Zimmer Biomet, Inc..
[173970069]
(b)(4). Concomitant medical products: mini humeral tray +5 mm thickness +0 mm taper offset 40 mm diameter cat 110031400 lot# 64336369. Bearing +3 mm thickness 40 mm diameter cat# 110031422 lot# 64291297. Glenosphere standard offset 40 mm diameter cat# 110030776 lot# 11024225. Comp aug mini bsplt w tpr md cat# 110032420 lot# 64155088. Comp rvs cntrl 6. 5x25mm st/rst cat# 115395 lot# 840070. Comp lk scr 3. 5hex 4. 75x15 st cat# 180550 lot# 462580. Comp lk scr 3. 5hex 4. 75x15 st cat# 180550 lot# 206550. Comp lk scr 3. 5hex 4. 75x30 st cat# 180553 lot# 750870. Comp lk scr 3. 5hex 4. 75x30 st cat# 180553 lot# 028290. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -00079, 0001825034 -2020 -00080, 0001825034 -2020 -00081, 0001825034 -2020 -00082, 0001825034 -2020 -00083, 0001825034 -2020 -00084.
Patient Sequence No: 1, Text Type: N, H10
[173970070]
It was reported the patient underwent a primary right total shoulder arthroplasty. Subsequently, the patient was noted to have an aspiration of a hematoma approximately 45 days later. The patient was also noted to have heterotopic ossification at the 6-month follow-up; however, no intervention was noted at this time and the patient continues to have improved outcome measures. 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 | 0001825034-2020-00078 |
| MDR Report Key | 9552532 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-08-29 |
| Date Mfgr Received | 2019-12-23 |
| Device Manufacturer Date | 2019-01-09 |
| Date Added to Maude | 2020-01-06 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPREHENSIVE MINI PRIMARY STEM |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | MBF |
| Date Received | 2020-01-06 |
| Model Number | NI |
| Catalog Number | 113633 |
| Lot Number | 996880 |
| 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 | 2020-01-06 |