MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-12-20 for CAPITATE STEM N/A UNK manufactured by Zimmer Biomet, Inc..
[130994327]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: part # unk, radial body, lot # unk, part # unk, carpal plate, lot # unk, part # unk, radial stem, lot # unk, part # unk, carpal head, lot # unk, part # unk, radial screw, lot # unk, part # unk, ulnar screw, lot # unk. Event occurred in (b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 11304, 0001825034 - 2018 - 11305, 0001825034 - 2018 - 11306, 0001825034 - 2018 - 11308, 0001825034 - 2018 - 11309, 0001825034 - 2018 - 11310.
Patient Sequence No: 1, Text Type: N, H10
[130994328]
It was reported that approximately 8 years post implantation, the patient had reports of swelling and pain to the wrist. During the first-stage revision, the surgeon had discovered loosening, migration and fracturing of the screws, and local metallosis. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-11307 |
| MDR Report Key | 8184163 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-12-20 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2019-01-03 |
| 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 | CAPITATE STEM |
| Generic Name | PROSTHESIS, WRIST |
| Product Code | KWN |
| Date Received | 2018-12-20 |
| Model Number | N/A |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 |