MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACETABULAR INSERT; HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Degraded (1153); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Injury (2348); Osteolysis (2377); Ambulation Difficulties (2544)

Event Date 01/01/2001

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: UNKNOWN ACETABULAR INSERT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5313540
• MDR Text Key: 33970743
• Report Number: 0002249697-2015-04345
• Device Sequence Number: 1
• Product Code: KWB
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR