MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER. LOW PROFILE ACETAB CUP; HIP IMPLANT

Catalog Number 0580-6-652

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 10/28/2016

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.

Event Description

The cra reported that aseptic acetabular loosening of a right thr had been noted during a monitoring visit.The patient underwent revision surgery.The implant had been in situ for 15 years and 6 months.

Manufacturer Narrative

The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.An event regarding loosening involving an exeter shell was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-medical records received and evaluation: a medical review was performed and concluded: "there is no information at all about the conditions surrounding the cup loosening.No clinical info, no x-rays or any other info.As such can this case not be solved with the current information.More info, especially x-rays would be required to solve this case." -device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: a medical review was performed and concluded: "there is no information at all about the conditions surrounding the cup loosening.No clinical info, no x-rays or any other info.As such can this case not be solved with the current information.More info, especially x-rays would be required to solve this case." if further information such as x-rays, patient history, additional operative notes and/or the device becomes available this investigation will be reopened.

Event Description

The cra reported that aseptic acetabular loosening of a right thr had been noted during a monitoring visit.The patient underwent revision surgery.The implant had been in situ for 15 years and 6 months.

• Brand Name: EXETER. LOW PROFILE ACETAB CUP
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6388443
• MDR Text Key: 69398766
• Report Number: 0002249697-2017-00828
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0580-6-652
• Device Lot Number: GY495691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• 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: 83 YR
• Patient Weight: 76