MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-05-16 for COMP RVRS SHLDR GLNSP STD 41MM N/A 115320 manufactured by Zimmer Biomet, Inc..
[108452902]
(b)(4). Concomitant: xl-115366, acrom xl 44-41 std hmrl brng, 855090. Pm555567, sorensen lt pm mini glen, 082640. The 115396, comp rvs cntrl 6. 5 x 30 mm st/rst, 114200. The 115397, comp rvs cntrl 6. 5 x 35 mm st/rst, 366060. The 180561, comp nlk scr 3. 5hex 4. 75x35 st, 203360. The 180560, comp nlk scr 3. 5hex 4. 75x30 st, 309190. The 115370, comp rvs tray co 44 mm, 935350. The 180559, comp nlk scr 3. 5hex 4. 75x25 st, 919750. The 118001, versa-dial/comp ti std taper, 323570. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03400.
Patient Sequence No: 1, Text Type: N, H10
[108452903]
It was reported that a patient underwent a revision surgery. Subsequently, for unknown reasons, the patient has experienced a dislocation as well as penetration of the skin by the implant. No further information is currently available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-03401 |
| MDR Report Key | 7519772 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-05-16 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-04-16 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2018-05-16 |
| 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 RVRS SHLDR GLNSP STD 41MM |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-05-16 |
| Model Number | N/A |
| Catalog Number | 115320 |
| Lot Number | 600250 |
| 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. Other | 2018-05-16 |