MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2018-07-27 for 8MM PT2 ALLPOLY TIB KRH XXSML 64852608 manufactured by Stryker Orthopaedics-mahwah.
[115365934]
It was noted that the device is not available for evaluation. Additional information has been requested. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[115365935]
Primary procedure, right knee. It was reported that after trialing, components were cemented in when it was discovered that the implants were much longer than the trials (trials and implants were matched). A surgical delay of 1 hour was caused by the need to explant all devices and re-implant devices which fit the patient. No tourniquet was used.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 0002249697-2018-02342 |
MDR Report Key | 7725803 |
Report Source | HEALTH PROFESSIONAL,OTHER |
Date Received | 2018-07-27 |
Date of Report | 2018-09-25 |
Date of Event | 2018-06-29 |
Date Mfgr Received | 2018-08-28 |
Device Manufacturer Date | 2017-01-17 |
Date Added to Maude | 2018-07-27 |
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. BRAD CURTIS |
Manufacturer Street | 325 CORPORATE DRIVE |
Manufacturer City | MAHWAH NJ 07430 |
Manufacturer Country | US |
Manufacturer Postal | 07430 |
Manufacturer Phone | 2018315000 |
Manufacturer G1 | STRYKER ORTHOPAEDICS-LIMERICK |
Manufacturer Street | RAHEEN BUSINESS PARK |
Manufacturer City | LIMERICK NA |
Manufacturer Postal Code | NA |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | 8MM PT2 ALLPOLY TIB KRH XXSML |
Generic Name | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, TRUNNION-BEARING |
Product Code | LGE |
Date Received | 2018-07-27 |
Catalog Number | 64852608 |
Lot Number | LPTC306 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2018-07-27 |