MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN EXETER ACETABULAR COMPONENT; HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Degraded (1153); Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 01/18/2016

Event Type  malfunction  

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.

Event Description

The customer reported that the patient had been implanted with an exeter stem, cup and head into the left hip and that it was noticed that the patient has acetabular component wearing.The head was reported to be eccentric.No treatment was required for the patient as the patient was asymptomatic.

Manufacturer Narrative

An event regarding acetabular component wear involving an unknown exeter shell was reported.The event was confirmed.Method and results: -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: the provided medical information was submitted to a consulting clinician who confirms poly wear and well fixed components with provided x-rays but deemed the information insufficient and rejected it for a medical review, further information such as primary and revision operative reports, needed serial x-rays, examination of explanted components are needed to complete the medical assessment.Conclusions: the reported event of the acetabular component wearing was confirmed by the consulting clinician but the exact cause of the event could not be determined because insufficient information was provided.The patient is asymptomatic.Further information such as primary and revision operative reports, serial x-rays, examination of explanted components are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

The customer reported that the patient had been implanted with an exeter stem, cup and head into the left hip and that it was noticed that the patient has acetabular component wearing.The head was reported to be eccentric.No treatment was required for the patient as the patient was asymptomatic.

• Brand Name: UNKNOWN EXETER ACETABULAR COMPONENT
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6389267
• MDR Text Key: 69740780
• Report Number: 0002249697-2017-00835
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2017
• 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): Other
• Patient Age: 90 YR