MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-01 for UNKNOWN HEAD UNK_REC manufactured by Stryker Orthopaedics-mahwah.
[61246301]
An event regarding pain and injury involving an accolade stem and an unknown head was reported. Disassociation was confirmed following visual inspection of the provided x-rays and explanted devices. Device evaluation and results: visual inspection was performed as part of the material analysis report (mar). Damage was observed on the taper of the head, likely from interacting with the trunnion of the accolade stem. Debris was also observed taper. " medical records received and evaluation: a review of the provided medical records and x-rays concluded: procedure-related factors: heterotopic ossifications are a procedure-related complication of any hip arthroplasty with patient-related sensitivity factors as well present. Patient-related factors sensitivity for development of heterotopic ossifications has genetic predisposition. Device-related factors: none as also supported by mar findings. Diagnosis: heterotopic ossifications in the superior hip joint space have contributed to bony impingement in external rotation with a resultant overload condition. Progressive corrosion due to excessive micromotion has caused catastrophic trunnion failure with femoral head disassociation requiring revision. " a review of the provided medical records and x-rays concluded "heterotopic ossifications in the superior hip joint space have contributed to bony impingement in external rotation with a resultant overload condition. Progressive corrosion due to excessive micromotion has caused catastrophic trunnion failure with femoral head disassociation requiring revision. " no further investigation for this event is possible at this time. If additional information such as patient details, histopathology reports, additional x-rays and sticker sheets become available, this investigation will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[61246302]
Patient rh went to emergency room on saturday (b)(6) 2016 regarding pain in the hip area. Doctor contacted rep regarding revision of hip and surgery on (b)(6) 2016 and found the device came apart.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2016-03807 |
| MDR Report Key | 6139067 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-01 |
| Date of Report | 2016-09-06 |
| Date of Event | 2016-09-04 |
| Date Mfgr Received | 2016-11-03 |
| Date Added to Maude | 2016-12-01 |
| 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-MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN HEAD |
| Generic Name | HIP IMPLANT |
| Product Code | OOG |
| Date Received | 2016-12-01 |
| Returned To Mfg | 2016-09-19 |
| Catalog Number | UNK_REC |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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; 2. Required No Informationntervention | 2016-12-01 |