MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/0; IMPLANT

Catalog Number 6260-9-136

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Purulent Discharge (1812); Pain (1994)

Event Date 02/18/2015

Event Type  Injury  

Event Description

Third party distributor, (b)(4), has reported on behalf of the customer, (b)(6), that a (b)(6) year old, female patient weighing (b)(6) has had to undergo an unanticipated revision on her right hip reportedly due to suffering from pain for a year.Whilst performing the surgery, (b)(6) reported that 60-70 ml of a cream coloured pus was observed, along with a thickened capsule.The customer has reported that the implants were removed and a spacer was inserted.The customer has reported that a specimen of the creamy coloured fluid was sent for culture and sensitivity testing along with a specimen of tissue from the femur and the acetabulum.The customer has reported that all specimens came back as clear.The customer has reported that the implants were initially implanted on (b)(6) 2009.Please note, all devices are available to return apart from 623-10-36e, lot 28940901.

Manufacturer Narrative

An event regarding infection and corrosion involving a v40 cocr lfit head was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection was completed as part of the mar dated 18th june 2015.Dark discoloration, adhered debris and material loss were observed throughout regions of the taper.The material analysis report concluded: portions of the femoral stem trunnion and femoral head taper surface were discolored and covered in dark adhered debris.The surfaces and debris were characteristic of a mechanically assisted corrosion process.No material or manufacturing defects were observed on the devices examined.-medical records received and evaluation: a review of the medical records and material analysis report by a clinical consultant diagnosed: infection of arthroplasty as procedure-related complication of total hip arthroplasty without device-related aspects.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the reported lot and the reported sterile lot.Conclusions: a review of the event by a clinical consultant diagnosed: infection of arthroplasty as procedure-related complication of total hip arthroplasty without device-related aspects.No further investigation is possible at this time.If additional information such as pathology reports become available, this investigation will be reopened.

• Brand Name: V40 COCR LFIT HEAD 36MM/0
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4924922
• MDR Text Key: 20671933
• Report Number: 0002249697-2015-02407
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 6260-9-136
• Device Lot Number: MET490
• Other Device ID Number: STERILE LOT: MSHET29A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2008
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 60