MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-09 for UHEAD STEM UNK_SEL manufactured by Stryker Gmbh.
[44802670]
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[44802671]
Consultant hand surgery/orthopaedic surgeon at (b)(6) hospital requested via the sbi distributor, (b)(4), the metal composition of the uhead and remotion implants. The hospital reported that a male, (b)(6) patient, had experienced swelling, a rash and itching ulnar and radial following wrist surgery. It was further reported that the patient underwent surgery using remotion implants on the (b)(6) 2010 and (b)(6) 2014, and underwent surgery using the uhead implants on (b)(6) 2015. It is further reported that the patient has not received any further treatment. The patient reports that he occasionally has a tingling in his mouth and tongue caused by a titanium dental implant that he has.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2016-00241 |
| MDR Report Key | 5641563 |
| Date Received | 2016-05-09 |
| Date of Report | 2016-04-13 |
| Date of Event | 2015-06-11 |
| Date Mfgr Received | 2016-04-13 |
| Date Added to Maude | 2016-05-09 |
| 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 | MR. ROSE HAAS |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER GMBH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UHEAD STEM |
| Generic Name | IMPLANT |
| Product Code | KXE |
| Date Received | 2016-05-09 |
| Catalog Number | UNK_SEL |
| Lot Number | UNKOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-09 |