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 2015-12-21 for UNKNOWN ACETABULAR INSERT UNK_SHC manufactured by Stryker Orthopaedics-mahwah.
[33970743]
It was indicated that none of the original implants were explanted during the surgery. The hospital is not releasing any patient details/medical records, post-op notes, etc. The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.
Patient Sequence No: 1, Text Type: N, H10
[33970744]
On (b)(6) 2015, the patient underwent a revision of a cementless left hip arthroplasty for severe wear of polyethylene acetabular, with widespread acetabular osteolysis and femoral and acetabular loosening dislocation of the implant. Intraoperatively, not being result can undertake re-implanting acetabular (for the serious lack of supporting osseous tissues, in particular in the acetabulum, but also to proximal femoral), so surgeon proceeded to explant acetabulum (with pins, screws and the insert of polyethylene) and to the resection of the proximal femoral stem, not espiantabile otherwise, without putting in serious jeopardy the integrity of the femur itself. The indications given about the implanted materials were obtained exclusively by the news reported by the patient because the clinical documentation related to the first surgery (2001? ) is not available. Therefore, the referring to "abg cotile" (stryker) and the "conus stem" (zimmer) from the surgeon are to be considered indicative only.
Patient Sequence No: 1, Text Type: D, B5
[38861878]
An event regarding wear involving an unknown liner was reported. The event was confirmed. Method and results: device evaluation and results: the device was not returned for analysis. Medical records received and evaluation: a review of the provided information by a clinical consultant could confirm the event but could not determine a root cause. Device history review could not be performed as the device details were not provided. Complaint history review could not be performed as the device details were not provided. Conclusions: the exact cause of the event could not be determined because insufficient information was provided. Further information such as device details, device return, additional x-rays, operative reports and patient medical records would be helpful in investigating this event further. If additional information and/or device become available, this investigation will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[38861879]
On (b)(6) 2015, the patient underwent a revision of a cementless left hip arthroplasty for severe wear of polyethylene acetabular, with widespread acetabular osteolysis and femoral and acetabular loosening dislocation of the implant. Intraoperatively, not being result can undertake re-implanting acetabular (for the serious lack of supporting osseous tissues, in particular in the acetabulum, but also to proximal femoral), so surgeon proceeded to explant acetabulum (with pins, screws and the insert of polyethylene) and to the resection of the proximal femoral stem, not espiantabile otherwise, without putting in serious jeopardy the integrity of the femur itself. The indications given about the implanted materials were obtained exclusively by the news reported by the patient because the clinical documentation related to the first surgery (2001? ) is not available. Therefore, the referring to "abg cotile" (stryker) and the "conus stem" (zimmer) from the surgeon are to be considered indicative only.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2015-04345 |
| MDR Report Key | 5313540 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2015-12-21 |
| Date of Report | 2015-11-30 |
| Date of Event | 2001-01-01 |
| Date Mfgr Received | 2016-01-27 |
| Date Added to Maude | 2015-12-21 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ACETABULAR INSERT |
| Generic Name | HIP IMPLANT |
| Product Code | KWB |
| Date Received | 2015-12-21 |
| 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 | 2015-12-21 |