MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,health p report with the FDA on 2019-03-01 for COMP PRIMARY STEM 7MM MINI N/A 113627 manufactured by Zimmer Biomet, Inc..
[137542337]
(b)(4). Medical products: part # 115310 lot # 990660 comp rvrs shldr glnsp std 36mm; part # 110005273 lot # 184150 comp cnv glen base non ha; part # xl-115363 lot # 588250 or 145510 arcom xl 44-36 std hmrl brng; part # 115375 lot # 822460 or 272100 comp rvs tray co 44mm ; part # 115395 lot # 650420 comp rvs cntrl 6. 5x25mm st/rst; part # 180551 lot # 969080 comp lk scr 3. 5hex 4. 75x20 st; part # 180552 lot # 715590 comp lk scr 3. 5hex 4. 75x25 st; part # 405883 lot # 538650 comp rvs 3. 2mm drl ; part # 405800 lot # 905620 comp. Rev shldr 9 in steinmann; part # 405889 lot # 538820 comp rvs 2. 7mm dia drl; part # 110005237 lot # 509950 comp conv glen liner e1; part # 118001 lot # 120880 versa-dial/comp ti std taper. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 00921; 0001825034 - 2019 - 00922; 0001825034 - 2019 - 00923; 0001825034 - 2019 - 00924; 0001825034 - 2019 - 00925; 0001825034 - 2019 - 00926. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[137542338]
It has been reported that patient is suffering from chronic pain and non functioning joint (9) nine months post revision surgery. Patient is undergoing seeking care under a pain management specialist. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-00920 |
| MDR Report Key | 8382201 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2019-03-01 |
| Date of Report | 2019-06-24 |
| Date of Event | 2018-09-11 |
| Date Mfgr Received | 2019-05-29 |
| Device Manufacturer Date | 2016-08-24 |
| Date Added to Maude | 2019-03-01 |
| 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 | COMP PRIMARY STEM 7MM MINI |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | MBF |
| Date Received | 2019-03-01 |
| Model Number | N/A |
| Catalog Number | 113627 |
| Lot Number | 292310 |
| 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. Required No Informationntervention; 2. Deathisabilit | 2019-03-01 |