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

Catalog Number UNK_REC

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 10/19/2014

Event Type  Injury  

Manufacturer Narrative

Two unknown 25mm torx screws were received and one was confirmed to be fractured.The investigation concluded that the screw fractured as a result of overloading conditions caused by the migrated, loosened shell.Acetabular screws are intended only for supplementary initial fixation and therefore the screws did not contribute to the shell loosening after 7 years service in-vivo.No further investigation is required.If additional information becomes available the investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

It was reported that patient was revised on a right hip due to a loose cup.Update: medical records received indicated revision of right hip performed on (b)(6) 2014 due to dislocation.The cup was noted to be "grossly subluxated pre-op" and "significant black corrosion" was observed at trunnion.A broken screw removed as well.The stem was not revised.

• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5141618
• MDR Text Key: 27971015
• Report Number: 0002249697-2015-03314
• 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: health professional,other
• Reporter Occupation: Physician
• Report Date: 10/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 79 YR
• Patient Weight: 106