MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-01-24 for MAESTRO TC CARPALHD 7X15MM STD N/A 180363 manufactured by Zimmer Biomet, Inc..
[98162903]
(b)(4). Concomitant medical products: 180350, variable lock screw 4. 75x15mm, 551350, 180354, variable lock screw 4. 75x35mm, 551310, 180151, maestro rad w/brg 7x15 7. 5 rt, 002440, 180395, maestro tc carpal plate 9x37mm, 605040, 180181, maestro radial stem 6. 0x40mm, 172020, 180320, maestro tc capitatestem 6x12mm, 091780. 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 - 00333, 0001825034 - 2018 - 00334, 0001825034 - 2018 - 00332, 0001825034 - 2018 - 00336. Product location unknown.
Patient Sequence No: 1, Text Type: N, H10
[98162904]
It was reported by the patient? S legal counsel that the patient underwent wrist arthroplasty. Subsequently, the patient is experiencing tingling, burning, pain in her fingers, a painful lump in her wrist, and loosening. Patient was referred to hand therapist for splint fabrication. No revision procedure has been reported to date. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
[122526076]
This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[122526077]
It was reported by the patient? S legal counsel that the patient underwent wrist arthroplasty. Subsequently, it is alleged that the patient is experiencing tingling, burning, and pain in her fingers, a painful lump in her wrist, loosening, as well as nerve/ tendon irritation from the prosthesis being too large for the patient. No revision procedure has been reported to date. No additional patient consequences were reported. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-00335 |
| MDR Report Key | 7217051 |
| Report Source | CONSUMER |
| Date Received | 2018-01-24 |
| Date of Report | 2018-03-09 |
| Date of Event | 2014-09-26 |
| Date Mfgr Received | 2018-03-08 |
| Device Manufacturer Date | 2014-06-25 |
| Date Added to Maude | 2018-01-24 |
| 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 | MAESTRO TC CARPALHD 7X15MM STD |
| Generic Name | PROSTHESIS, WRIST |
| Product Code | KWN |
| Date Received | 2018-01-24 |
| Model Number | N/A |
| Catalog Number | 180363 |
| Lot Number | 457600 |
| 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 | 2018-01-24 |