MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/-5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-036

Device Problems Corroded (1131); Degraded (1153); Metal Shedding Debris (1804); Material Integrity Problem (2978)

Patient Problems Inflammation (1932); Injury (2348); Test Result (2695)

Event Date 07/06/2015

Event Type  Injury  

Event Description

The customer (b)(6) reported that the patient underwent a scheduled revision of a femoral head and acetabular liner for the left hip on (b)(6) 2015 at (b)(6) hospital.The customer reported that some black colored debris was seen within the femoral head when removed from the stem taper and some debris was on the taper as well.The customer reported that the surgeon was concerned about the taper wear from the femoral head.The patient's blood cobalt levels were reported to be slightly raised with a value of 35nmol/l in (b)(6) 2015.The date of the primary implant was given as (b)(6) 2012.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding corrosion and elevated ion levels involving a metal head was reported.The event of corrosion was confirmed.The reported elevated metal ion levels could not be confirmed.Method & results: -device evaluation and results: material analysis confirmed the presence of corrosion on the returned metal head.No material or manufacturing defects were observed.-medical records received and evaluation: insufficient medical records were received for review with a clinical consultant.-device history review: there have been no reported discrepancies for the referenced lot.-complaint history review: there have been no reported events for the lot referenced.Conclusions: the exact cause of the event could not be determined because further information such as patient history and follow-up notes are needed to complete the investigation for determining the root cause.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available, this investigation will be reopened.

Event Description

The customer tekno reported that the patient underwent a scheduled revision of a femoral head and acetabular liner for the left hip on (b)(6) 2015 at (b)(6) hospital.The customer reported that some black colored debris was seen within the femoral head when removed from the stem taper and some debris was on the taper as well.The customer reported that the surgeon was concerned about the taper wear from the femoral head.The patient's blood cobalt levels were reported to be slightly raised with a value of 35nmol/l in (b)(6) 2015.The date of the primary implant was given as (b)(6) 2012.

Manufacturer Narrative

Medical records received and evaluation: a medical review was performed and concluded: "given the reported cobalt value of 35 nmol/l in this arthroplasty patient, this value should be considered normal and not an indication of some metal-related type of problem or even risk factor for such." [.] "no indication for device-related matters as also supported by the mar findings.This pi case is not device-related." [.] "diagnosis: cup malposition in absent anteversion has contributed to an overload condition in the arthroplasty potentially contributing to corrosion effects in the taper junction with marginal or absent adverse clinical effects." conclusions: a medical review was performed and concluded "cup malposition in absent anteversion has contributed to an overload condition in the arthroplasty potentially contributing to corrosion effects in the taper junction with marginal or absent adverse clinical effects".There was no evidence of a device related issue.Further to this a material analysis was performed and concluded that "no material or manufacturing defects were observed on the surfaces examined." additional information, including operative reports, progress notes, pathology reports and series x-rays are however needed to fully investigate the event.No further investigation is required.If further information becomes available this investigation will be re-opened.

Event Description

The customer (b)(6) reported that the patient underwent a scheduled revision of a femoral head and acetabular liner for the left hip on (b)(6) 2015 at (b)(6).The customer reported that some black colored debris was seen within the femoral head when removed from the stem taper and some debris was on the taper as well.The customer reported that the surgeon was concerned about the taper wear from the femoral head.The patient's blood cobalt levels were reported to be slightly raised with a value of 35nmol/l in (b)(6) 2015.The date of the primary implant was given as (b)(6) 2012.

• Brand Name: V40 COCR LFIT HEAD 36MM/-5
• 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: 4965378
• MDR Text Key: 17546975
• Report Number: 0002249697-2015-02552
• Device Sequence Number: 1
• Product Code: JDI
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2015

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: 05/31/2015
• Device Catalogue Number: 6260-9-036
• Device Lot Number: MLHNJX
• Other Device ID Number: STERILE LOT# MSHLJ09A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 08/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/09/2012
• 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 Weight: 90