MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40(TM). FEMORAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6364-2-036

Device Problems Device Expiration Issue (1216); Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/22/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the surgeon had implanted a size 36 stainless steel femoral head that was 6 weeks out of expiry date.The expiry date was noted during surgery and the surgeon had checked whether an in date device could be obtained from a neighbouring hospital while the patient was in surgery.The surgeon then took a decision to implant the out of date device rather than incur a time delay in surgery because the stem and cup were already in place.The surgeon is querying whether there is an infection risk as a result of this.The hospital does have an implant checking procedure prior to surgery.

Manufacturer Narrative

Based on the provided information, the product reported was used after expiration of its epiry date.The use of expired products memo attached states that "stryker orthopaedics applies a five (5) year expiry date to all sterile products.{.} product beyond its expiry date must not be used as its safety and effectiveness cannot be predicted.".

Event Description

The customer reported that the surgeon had implanted a size 36 stainless steel femoral head that was 6 weeks out of expiry date.The expiry date was noted during surgery and the surgeon had checked whether an in date device could be obtained from a neighbouring hospital while the patient was in surgery.The surgeon then took a decision to implant the out of date device rather than incur a time delay in surgery because the stem and cup were already in place.The surgeon is querying whether there is an infection risk as a result of this.The hospital does have an implant checking procedure prior to surgery.

• Brand Name: V40(TM). FEMORAL HEAD
• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5664558
• MDR Text Key: 46220960
• Report Number: 0002249697-2016-01650
• 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: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 6364-2-036
• Device Lot Number: G3089973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2011
• 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