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

Catalog Number UNK_REC

Device Problem Fracture (1260)

Patient Problems Fall (1848); Injury (2348)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

Sales rep reported revision of left hip.The patient was revised due to a fall whereby the acetabular cup fractured.The stryker cup was removed and was replaced by a zimmer cup.Two screws, the liner, and head were also replaced.The stem was well fixated and was not removed.

Manufacturer Narrative

An event regarding revision due to crack/fracture of a unknown shell involving an unknown shell was reported.The event was not confirmed.Device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: not performed as the device was not properly identified.Complaint history review: not performed as the device was not properly identified the event could not be confirmed nor the root cause determined as sufficient information was not provided.Further information such as return of device, operative reports, x-rays, histapathology reports, patient history and follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

Sales rep reported revision of left hip.The patient was revised due to a fall whereby the acetabular cup fractured.The stryker cup was removed and was replaced by a zimmer cup.Two screws, the liner, and head were also replaced.The stem was well fixated and was not removed.

• Brand Name: UNKNOWN SHELL
• Type of Device: HIP 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6614305
• MDR Text Key: 76741539
• Report Number: 0002249697-2017-01784
• Device Sequence Number: 1
• Product Code: MEH
• 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
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: 08/16/2017
• Supplement Dates FDA Received: 09/12/2017
• 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: 74 YR
• Patient Weight: 54