MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2017-01-03 for UNKNOWN ACCOLADE TMZF HIP STEM UNK_SHC manufactured by Stryker Orthopaedics-mahwah.
[63734440]
The information in this report was provided by stryker orthopaedics legal affairs department. No additional information is available at this time due to the ongoing litigation. Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[63734441]
It was reported through the filing of a lawsuit that allegedly after implantation the patient began experiencing discomfort in the area of his device and developed an audible clunk in his hip when he walked. It is further alleged that initial diagnostic workup revealed gross failure of the accolade trunnion and marked elevation of serum cobalt, chromium and titanium and as a result the patient was forced to have the device surgically removed.
Patient Sequence No: 1, Text Type: D, B5
[69136934]
This event has been identified as a duplicate. Investigation results and conclusions are documented under mfr#0002249697-2015-00789.
Patient Sequence No: 1, Text Type: N, H10
[69136935]
It was reported through the filing of a lawsuit that allegedly after implantation the patient began experiencing discomfort in the area of his device and developed an audible clunk in his hip when he walked. It is further alleged that initial diagnostic workup revealed gross failure of the accolade trunnion and marked elevation of serum cobalt, chromium and titanium and as a result the patient was forced to have the device surgically removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2017-00017 |
| MDR Report Key | 6218492 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2017-01-03 |
| Date of Report | 2017-02-27 |
| Date of Event | 2016-12-05 |
| Date Mfgr Received | 2017-02-03 |
| Date Added to Maude | 2017-01-03 |
| 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. KEYLA COLON |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-CORK |
| Manufacturer Street | IDA INDUSTRIAL ESTATE |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ACCOLADE TMZF HIP STEM |
| Generic Name | HIP IMPLANT |
| Product Code | ISL |
| Date Received | 2017-01-03 |
| Catalog Number | UNK_SHC |
| Lot Number | UNKNOWN |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-01-03 |