MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-12-20 for ARCOM XL 44-36 STD HMRL BRNG N/A XL-115363 manufactured by Zimmer Biomet, Inc..
[131010930]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Unique identifier (udi) #: n/a. Concomitant medical products: part # 115340, comp rvs hmrl ti tray 44mm, lot # 963700; part # 115330, comp rvrs shdr glen bsplt +ha, lot # 319980; part # 118001, versa-dial/comp ti std taper, lot # 739270; part # 115385, comp rvs cntrl scr 6. 5x45mm st; part # 180502, comp locking screw 4. 75x25mm, lot # 532020; part # 180511, comp non-lckng screw 4. 75x35mm, lot # 852750; part # 180510, comp non-lckng screw 4. 75x30mm, lot # 852660; part # 115313, comp rvsr shldr glnsp +3 36mm, lot # 179470; part # 113649, comp primary stem 9mm std, lot # 923820. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 11370.
Patient Sequence No: 1, Text Type: N, H10
[131010931]
It was reported that approximately 7 years post implantation, the patient underwent a revision due to pain, loss of range of motion, and fracturing of the humeral tray. The humeral tray and poly liner were the only components revised. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-11371 |
| MDR Report Key | 8184524 |
| Report Source | OTHER |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-17 |
| Date of Event | 2017-05-25 |
| Date Mfgr Received | 2018-12-05 |
| Device Manufacturer Date | 2010-03-24 |
| Date Added to Maude | 2018-12-20 |
| 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 | ARCOM XL 44-36 STD HMRL BRNG |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-12-20 |
| Model Number | N/A |
| Catalog Number | XL-115363 |
| Lot Number | 640710 |
| Device Expiration Date | 2015-03-24 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-12-20 |