MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM +0(STD) V40 TRIAL HEAD; HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

Catalog Number 6264-8-128R

Device Problems Degraded (1153); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device discarded by hospital.

Event Description

The customer reported that over the weekend she noticed that some of the heads on their exeter sets had black material coming from behind and around the retentive orange ring.The customer has raised this as a contamination risk and is looking to replace all the retentive heads on their sets with non-retentive heads.The devices are in a newly consigned kit which has not previously been used by this hospital but may have been used on other customers previously.The customer has indicated that cssd had removed the rings to clean the heads.The devices are cleaned by hand, and then treated ultrasonically.Finally they are put through the washer.Details of the cleaning agents used were unknown on intake.The customer is asking for clarification about the correct way to clean the heads and whether removing the retentive ring is appropriate.As this was noticed prior to use, there was no patient involvement.

Manufacturer Narrative

An event regarding cleaning issues involving a v40 head trial was reported.The event was confirmed.Method & results: -device evaluation and results: the device was not returned but images were provided.The image showed that the device has scratches on the exterior surface.The o-ring appears worn.-medical records received and evaluation: clinician review was not requested as the event is unrelated to patient factors.No adverse consequences to a patient were reported as the event occurred during inspection.-device history review a review of the device history records could not be performed as no lot information was provided.-complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the investigation concluded that the alleged cleaning issues were caused by not following proper cleaning procedures.Details of the cleaning and sterilization can be found in the surgical protocol and also the package insert qin 4333.There was no mention of removal of the o-ring during cleaning process.Therefore, the reported instrument is not intended to be disassembled during cleaning process.If additional information becomes available, this investigation will be reopened.

Event Description

The customer reported that over the weekend she noticed that some of the heads on their exeter sets had black material coming from behind and around the retentive orange ring.The customer has raised this as a contamination risk and is looking to replace all the retentive heads on their sets with non-retentive heads.The devices are in a newly consigned kit which has not previously been used by this hospital but may have been used on other customers previously.The customer has indicated that cssd had removed the rings to clean the heads.The devices are cleaned by hand, and then treated ultrasonically.Finally they are put through the washer.Details of the cleaning agents used were unknown on intake.The customer is asking for clarification about the correct way to clean the heads and whether removing the retentive ring is appropriate.As this was noticed prior to use, there was no patient involvement.

• Brand Name: 28MM +0(STD) V40 TRIAL HEAD
• Type of Device: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER SUZHIOU; no. 18 wuxiang, epz zone a; 200 suhong road, sip; suzhou NJ 21502 1; CN 215021
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5054626
• MDR Text Key: 25627319
• Report Number: 0002249697-2015-02920
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122853
• 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: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2018
• Device Catalogue Number: 6264-8-128R
• Device Lot Number: AA137067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other