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 2017-11-02 for UNKNOWN SMOOTH PEG N/A manufactured by Zimmer Biomet, Inc..
[90932508]
(b)(4). Multiple mdrs were submitted for this event. Please see reports: 0001825034 - 2017 - 09851, 0001825034 - 2017 - 09852, 0001825034 - 2017 - 09853, 0001825034 - 2017 - 09854, 0001825034 - 2017 - 09855, 0001825034 - 2017 - 09856, 0001825034 - 2017 - 09857. Concomitant medical products: dvr anatomic short right, unknown part/lot, multi directional screw, unknown part/lot, qty: 2, smooth peg, unknown part/lot, qty: 4, ulnar component, unknown part/lot. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[90932509]
It was reported the patient was revised to address implant failure and pain. Because of the wrist collapsing, the ulnar implant leaned medially and worn into the bone causing wear/grooves into a couple of the pegs. No further information has been made available at this time.
Patient Sequence No: 1, Text Type: D, B5
[118005210]
This follow-up report is being submitted to relay additional information. X rays were evaluated and the reported event was confirmed. Dhr review was unable to be performed as the lot number of the device involved in the event is unknown. X-ray review confirmed fracture of the distal radius; it was fixed with volar plate and screws, and has healed with malalignment of the distal fracture fragment. Position of the plate and orientation of the screws suggests malalignment of the distal radius likely occurred postoperatively, possibly due to lack of adequate fixation or other etiologies such as trauma. Lack of fracture fixation could possibly be due to too short of distal radius volar plate without adequate plating proximal to the fracture site. A distal ulnar arthroplasty prosthesis is also present, the head of which abuts the proximal cortex of the lunate. There is subchondral lucency of the proximal lunate, as well as diffuse sclerosis of the lunate. 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
[118013427]
This follow-up report is being submitted to relay additional information. 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
| Report Number | 0001825034-2017-09855 |
| MDR Report Key | 6997086 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-11-02 |
| Date of Report | 2017-12-07 |
| Date of Event | 2017-10-05 |
| Date Mfgr Received | 2017-12-07 |
| Date Added to Maude | 2017-11-02 |
| 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 | UNKNOWN SMOOTH PEG |
| Generic Name | PROSTHESIS, EXTREMITY |
| Product Code | KXE |
| Date Received | 2017-11-02 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| 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. Required No Informationntervention | 2017-11-02 |