MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-372

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

It has been reported that the yellow plastic clip was bent and therefore the stem could not be loaded onto the introducer.

Manufacturer Narrative

Additional information: expiration date; manufacturing date; an event regarding damage involving an exeter stem was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no items were reviewed.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information were received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It has been reported that the yellow plastic clip was bent and therefore the stem could not be loaded onto the introducer.

• Brand Name: EXETER V40 STEM 37.5MM NO 2
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6953126
• MDR Text Key: 90203159
• Report Number: 0002249697-2017-03024
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 0580-1-372
• Device Lot Number: G7039780
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other