MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_LIM_PRODUCT; IMPLANT

Catalog Number UNK_LIM

Device Problem Device Inoperable (1663)

Patient Problem Unspecified Infection (1930)

Event Date 06/01/2012

Event Type  Injury  

Event Description

As per op report, "infection continued and cause failed left total knee arthroplasty secondary to infection and failed extensor mechanism allograft.".

Manufacturer Narrative

During a review of an operative report for another event, this event was discovered.No catalog numbers or lot codes were provided.The device was described as an unknown gmrs knee and unknown cerclage wires were also mentioned.It cannot be determined which, if either of these devices may have caused or contributed to the patient's experience.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

As per op report, "infection continued and cause failed left total knee arthroplasty secondary to infection and failed extensor mechanism allograft.".

Manufacturer Narrative

The patient is (b)(6) inches in height.An event regarding infection involving an unknown implant femoral component was reported.The event was confirmed.Method and results: device evaluation and results: not performed as the device was not returned for evaluation.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated that this complicated, multiply revised total knee arthroplasty was entirely the result of the persistent periprosthetic infection.Device history review: not performed as the lot id was not provided.Complaint history review: not performed as the lot id was not provided.Conclusions: based on clinical review of the provided medical results concluded that there is no evidence that this clinical picture was the result of factors of faulty component design, manufacturing, or materials.A capa trend analysis was conducted for the reported failure mode and concluded infection is a known possible adverse outcome of surgery and is beyond stryker's control.

• Brand Name: UNKNOWN_LIM_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4353241
• MDR Text Key: 5145658
• Report Number: 0002249697-2014-04823
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2015
• 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: 59 YR
• Patient Weight: 65