MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-352

Device Problems Connection Problem (2900); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.Device was implanted.

Event Description

The customer reported that he tried to load the exeter onto the introducer and the spigot didn't fit the introducer.The exeter was implanted manually as no other introducer was available at the time.The case was completed successfully and the surgeon was happy with the outcome.There were no adverse consequences or delays to surgery as a result of the reported event.

Manufacturer Narrative

An event regarding a size/fit and assembly issue involving an exeter stem and introducer was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: not performed as medical records were not received for evaluation.-device history review: device history review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies -complaint history review: a review of the complaint history database indicated that there have been no other similar events for the reported lot.Conclusions: a root cause of could not be determined as the device was not returned for analysis and insufficient information was provided.No further investigation is possible at this time.If additional information and/or device becomes available this record will be reopened.

Event Description

The customer reported that he tried to load the exeter onto the introducer and the spigot didn't fit the introducer.The exeter was implanted manually as no other introducer was available at the time.The case was completed successfully and the surgeon was happy with the outcome.There were no adverse consequences or delays to surgery as a result of the reported event.

• Brand Name: EXETER V40 STEM 37.5MM NO 0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 5317718
• MDR Text Key: 34781791
• Report Number: 0002249697-2015-04472
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K121308
• 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: 12/02/2015

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 Expiration Date: 07/31/2020
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G5717458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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