MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2013-01-22 for TROCHANTERIC GRIP WITH 2 CABLE 6704-3-070 manufactured by Stryker Orthopaedics-mahwah.
[3120282]
It was reported that: patient had revision surgery in (b)(6) 2012. At the time of revision surgery, patient had staple surgically implanted to help hold the hip implant. Patient is reporting having pain and will have staple removed. Patient states that she has retained a lawyer.
Patient Sequence No: 1, Text Type: D, B5
[10442283]
Catalogue number unknown at this time. Device description reported as unknown right stryker hip. The information in this report was provided by the patient who has retained a lawyer. No additional information is available at this time. Should additional information become available, the evaluation summary will be submitted in a supplemental report. (b)(4): not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[27921452]
The patient is (b)(6). An event regarding a revision due to pain involving a trochanteric grip with 2 cable was reported. The event was confirmed. A review of the provided operative reports, office notes, radiology reports, and x-rays by a clinical consultant indicated:? There is no examination of the explanted components, no pathology report confirming the diagnosis of altr, and no mri image or report of altr to review. There is no confirmation that this patient? S symptoms were due to altr from the stem/neck modular junction corrosion products. Her persistent trochanteric bursitis and chronic pain syndrome suggest that these problems may have been responsible for the patient? S pre-revision symptoms.? A conversation with the clinical consultant noted that the conclusion refers to both the patients pre and post revision symptoms. Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification. Complaint history review: a complaint history review confirmed no other similar events for the reported lot. Conclusions: a review of the provided medical records by a clinical consultant indicated that the trochanteric bursitis and chronic pain syndome may have been responsible for the patient? S symptoms. Additionally, the review by a clinical consultant stated that the cause of the pain is likely related to patient factors. A capa trend analysis was conducted for the reported failure mode and concluded pain may result from other factors not necessarily related to the device.
Patient Sequence No: 1, Text Type: N, H10
[27921453]
It was reported that: patient had revision surgery in (b)(6) 2012. At the time of revision surgery, patient had staple surgically implanted to help hold the hip implant. Patient is reporting having pain and will have staple removed. Patient states that she has retained a lawyer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2013-00139 |
| MDR Report Key | 2925476 |
| Report Source | 00,04 |
| Date Received | 2013-01-22 |
| Date of Report | 2013-01-03 |
| Date of Event | 2012-05-01 |
| Date Mfgr Received | 2014-10-08 |
| Device Manufacturer Date | 2012-02-20 |
| Date Added to Maude | 2013-01-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. BEVERLY LIMA |
| 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 NJ 07430NA |
| Manufacturer Postal Code | 07430 NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TROCHANTERIC GRIP WITH 2 CABLE |
| Generic Name | IMPLANT |
| Product Code | LYT |
| Date Received | 2013-01-22 |
| Catalog Number | 6704-3-070 |
| Device Expiration Date | 2017-02-28 |
| Operator | LAY USER/PATIENT |
| 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. Required No Informationntervention | 2013-01-22 |