MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-136

Device Problems Material Discolored (1170); Material Integrity Problem (2978)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 01/16/2014

Event Type  Injury  

Manufacturer Narrative

An event regarding infection involving a metal head was reported.The event was confirmed.Method & results: device evaluation and results: micro motion and corrosion were observed around the circumference of the machined tapered surface of the head.The black debris was found to be made of cr, mo, co, ca and ti.Ca is typical of biological material, the high cr and mo level with respect to the co level indicates corrosion products and the ti is material transfer from the stem (not returned).No material or manufacturing defects were observed on the components examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: "the operative report notes a previous incision and drainage of the right total hip arthroplasty had positive fungal cultures at five weeks.There is no histopathology or gross description of findings at revision surgery of (b)(6) 2014 of the right hip to suggest altr.There are no documented increased cobalt or chromium levels.There is no examination of the explanted components relative to the left hip, no histopathology or culture and sensitivity results from the (b)(6) 2014 left hip surgery, and no x-ray images available.There is no evidence that the clinical situation described in the left hip is not due to fungal infection, which was noted previously as the etiology in the right hip with a similar problem.The incidental findings of corrosion product in the modular junction of a metallic head does not in itself represent a diagnosis of metallosis or trunnionosis.In this complicated case of a patient with multiple comorbidities, there is no evidence that factors of faulty hip component design, manufacturing or materials were responsible for any clinical problems.¿ review of provided lab results by a stryker sr.Principal scientist indicated: "all sterile lot certificates for the implants utilized were reviewed for accuracy.There were no deviations ¿ including under dosing or reprocessing ¿ noted.Additionally, all packaging information was reviewed, and no deviations were identified.Based on the data reviewed, it has been determined that the introduction of the reported causative agents of this post-operation infection was not via the medical devices (i.E.: metal stem, femoral head, or acetabular cup; uhmwpe insert)." device history review: all devices accepted into final stock conformed to specification.Complaint history review indicated there have been no other events for the reported lot and the sterile lot.Conclusions: the root cause of the reported event could not be determined as histopathology or culture and sensitivity results were not provided.A review of the medical records by the clinician indicated "there is no evidence that factors of faulty hip component design, manufacturing or materials were responsible for any clinical problems.¿ a review of the medical records by a stryker sr.Principal scientist indicated: "based on the data reviewed, it has been determined that the introduction of the reported causative agents of this post-operation infection was not via the medical devices." no further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Dr (b)(6) wanted to do an i&d on a hip.Abnormal tissues were found.Multiple cultures were taken with no infection acute infection found.After exchanging the polyethylene dr (b)(6) noticed the x3 liner was oxidized and was very discolored (yellow).Dr (b)(6) then decided to replace the poly with the same type liner (36 neutral x3).Patient had an injection from another doctor and noticed strange colored fluid in the aspiration.

• Brand Name: V40 COCR LFIT HEAD 36MM/0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5565686
• MDR Text Key: 42264610
• Report Number: 0002249697-2016-01180
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• 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
• Report Date: 01/17/2014

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: 07/31/2014
• Device Catalogue Number: 6260-9-136
• Device Lot Number: MHKN4V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2016
• Initial Date FDA Received: 04/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2009
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 50 YR