MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-441

Device Problems Failure to Align (2522); Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978)

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

Event Date 10/13/2016

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.

Event Description

The customer reported that the yellow attachment device on the exeter v40 stem didn't attach correctly to the introducer handler and didn't line up correctly.This was noticed during a total hip replacement surgery as the scrub nurse was getting the femoral stem implant ready.She noticed the implant was not fitting on to the stem introducer and tried with more force.The yellow plastic part, the attachment drive, partially came off the implant.The scrub nurse got another implant without any delay.

Manufacturer Narrative

An event regarding a damage issue involving a spigot protector for an exeter stem was reported.The event was confirmed.Method and results: - device evaluation and results: a visual inspection of the returned device was carried out by the supplier.They noted "the exeter stem is in good condition.No mark appears on its surface.The yellow spigot shows a bent lug.The bent is so high that the carbonate of the spigot is broken and a small piece of the leg is almost spare out from the spigot.We can see high material deformation on the bent lug, exactly located on the area where the stem inserter has to connect with the spigot".Dimensional and functional inspection was not performed as the returned device was too damaged to allow either dimensional or functional inspection.-medical records received and evaluation: not performed as no 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 relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: the investigation performed by the supplier on the returned part concluded "that bent spigots are not due to manufacturing defect.The returned spigot shows bent lugs and visual marks of material bulge that are consistent with a misuse of the device".

Event Description

The customer reported that the yellow attachment device on the exeter v40 stem didn't attach correctly to the introducer handler and didn't line up correctly.This was noticed during a total hip replacement surgery as the scrub nurse was getting the femoral stem implant ready.She noticed the implant was not fitting on to the stem introducer and tried with more force.The yellow plastic part, the attachment drive, partially came off the implant.The scrub nurse got another implant without any delay.

• Brand Name: EXETER V40 STEM 44MM NO 1
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6100956
• MDR Text Key: 60292160
• Report Number: 0002249697-2016-03587
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/03/2017

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: 04/30/2021
• Device Catalogue Number: 0580-1-441
• Device Lot Number: G5964400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• 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