MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN RESTORATION MODULAR CONE CONICAL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number UNK_SHC

Device Problem Insufficient Information (3190)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

A patient specific implant prescription form for the patient's proximal femur was submitted.Noted on the form: "imminent fracture.Implant close to breaching anterior cortex.Potentially a mets proximal femur will suffice." proposed date of surgery is blank.As reported by rep : "right prox femur is being revised - there is currently a cone conical in-situ." rep confirmed in-situ device is restoration modular cone conical.

Event Description

Update per received information: "it was not a stryker product in situ.It was wrongly identified on the x-ray." a patient specific implant prescription form for the patient's proximal femur was submitted.Noted on the form: "imminent fracture.Implant close to breaching anterior cortex.Potentially a mets proximal femur will suffice." proposed date of surgery is blank.As reported by rep : "right prox femur is being revised - there is currently a cone conical in-situ." rep confirmed in-situ device is restoration modular cone conical.

Manufacturer Narrative

Corrected data: upon further investigation, it was determined that the previously reported "unknown restoration modular cone conical" was incorrectly identified, during x-ray review.It has since been confirmed that the device in question is a competitor product.Therefore, event is not reportable.

• Brand Name: UNKNOWN RESTORATION MODULAR CONE CONICAL
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10819643
• MDR Text Key: 215617137
• Report Number: 0002249697-2020-02397
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR