MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ETS. HIP ENDOPROSTHESIS; IMPLANT

Catalog Number 0590-3-042

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2015

Event Type  malfunction  

Event Description

It was reported that the winged tipped centraliser within ets 42 mm ref (b)(4), lot g5513468 was broken within the sterile packaging when opened.A further prostheses was opened for the winged tip centraliser.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.Device not available.

Manufacturer Narrative

An event regarding crack/fracture involving an exeter centralizer was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed, the centraliser was not returned, it was discarded by the customer.-medical records received and evaluation: insufficient medical records were received for review with a clinical consultant.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as photos of the centralizer or its return are needed to complete the investigation for determining root cause.If devices and / or additional information become available, this investigation will be reopened.

Event Description

It was reported that the winged tipped centraliser within ets 42 mm (b)(4) lot g5513468 was broken within the sterile packaging when opened.A further prostheses was opened for the winged tip centraliser.

• Brand Name: ETS. HIP ENDOPROSTHESIS
• Type of Device: 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4654156
• MDR Text Key: 5605192
• Report Number: 0002249697-2015-01037
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 0590-3-042
• Device Lot Number: G5513468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2014
• 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