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

Catalog Number UNK_REC

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/08/2014

Event Type  Injury  

Event Description

Surgeon reports patient a status post right hip done on (b)(6) 2014 is in need of a head exchange to increase leg length.Surgeon reported patient had a periprosthetic fracture four weeks after surgery which was treated non operative per patient request.The stem subsided and now the patient had a shortened leg length.Surgeon attempted to revise the hip through the anterior approach.Upon removing the head the femur was fractured intra operatively.Surgeon decided to implant a restoration modular stem as well as cable to reduce fracture.Restoration modular was implanted per surgical technique.Cables were applied.Leg length and stability checked to surgeons satisfaction.Surgical site was closed.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown short citation stem.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Device not returned.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4356721
• MDR Text Key: 20783593
• Report Number: 0002249697-2014-04960
• Device Sequence Number: 1
• Product Code: JDI
• 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
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 77