MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-9-340

Device Problems Detachment Of Device Component (1104); Degraded (1153); Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Injury (2348); Joint Dislocation (2374); No Information (3190)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision of stem due to head being displaced from trunnion.

Manufacturer Narrative

An event regarding disassociation involving a metal head was reported.The event was confirmed.Method and results: device evaluation and results: the device was not returned but images were provided.The head appears intact.Black debris was observed on the taper.Medical records received and evaluation: a review of the provided photographs of explanted components and undated x-rays by a clinical consultant indicated: ¿no clinical or past medical history, no operative reports or examination of the explanted components, and no dated serial x-rays are available for review.Based upon the information available for review, no determination can be made regarding the cause of this clinical situation eight-and-three-quarter years post-implantation of the right total hip arthroplasty.¿ 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 exact cause of the reported event could not be confirmed as additional information such as clinical or past medical history; operative reports, dated x-rays and examination of the explanted components are needed to complete the assessment.Review of the medical records indicated ¿¿no determination can be made regarding the cause of this clinical situation eight-and-three-quarter years post-implantation of the right total hip arthroplasty.¿ additionally, the lot number for the device was not provided, therefore, manufacturing records could not be reviewed.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and /or additional information become available, this investigation will be reopened.

Event Description

Revision of stem due to head being displaced from trunion.

Event Description

Revision of stem due to head being displaced from trunnion.Update per additional information received: it was reported through the filing of a lawsuit that allegedly after implantation of the device the patient began experiencing discomfort in the area of his device and later catastrophic total hip replacement failure with trunnionosis and a femoral neck fracture with dissociation of the femoral head.It is further alleged that as a result the patient was forced to have the devices surgically removed and during removal, it was apparent the device had failed causing gross deformation of the accolade tmzf stem together with severe and permanent tissue and muscle damage.".

Manufacturer Narrative

Additional information provided in section device manufacture date.An event regarding disassociation involving a metal head was reported.The event was confirmed.Method & results: -device evaluation and results: the device was not returned but images were provided.The head appears intact.Black debris was observed on the taper.-medical records received and evaluation: a review of the provided photographs of explanted components and undated x-rays by a clinical consultant indicated: ¿no clinical or past medical history, no operative reports or examination of the explanted components, and no dated serial x-rays are available for review.Based upon the information available for review, no determination can be made regarding the cause of this clinical situation eight-and-three-quarter years post-implantation of the right total hip arthroplasty.¿ -device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies -complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the reported event could not be confirmed as additional information such as clinical or past medical history; operative reports, dated x-rays and examination of the explanted components are needed to complete the assessment.Review of the medical records indicated ¿¿no determination can be made regarding the cause of this clinical situation eight-and-three-quarter years post-implantation of the right total hip arthroplasty.¿ the subject device has been identified to be within scope of ra 2016-028.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before (b)(6)2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and /or additional information become available, this investigation will be reopened.

• Brand Name: V40 COCR LFIT HEAD 40MM/+8
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5678163
• MDR Text Key: 45861441
• Report Number: 0002249697-2016-01716
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K061434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2018

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: 12/30/2011
• Device Catalogue Number: 6260-9-340
• Device Lot Number: HVMMRA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: Not provided; 06/06/2018
• Supplement Dates FDA Received: 09/28/2016; 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 86