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 Degraded (1153); Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 04/06/2015

Event Type  Injury  

Manufacturer Narrative

An event regarding stem fracture was reported, as part of the investigation, wear of the head was noted.Method & results: burnishing and wear was observed on the taper surfaces, consistent with movement against the stem trunnion.The articulating surface of the head did not have any remarkable indications of note.The material analysis report concluded that movement between the femoral head taper and the femoral stem trunnion caused wear and material loss within the taper junction.Due to the damages present on the taper and trunnion surfaces, it was not possible to evaluate the condition of the taper lock that permitted movement to occur.No material or manufacturing defects were observed on the device features examined.A review by a clinical consultant noted: the surgical report describes the technicalities of device exchange but reports no facts or findings that could help understand why this stem failed in the first place.The mar documents the catastrophic taper damage but is not able to establish a root cause for failure.No x-rays are available for review and as such it is not possible to evaluate the role of any potential procedure-related factors in the failure mode.From the available records, no info is available to suggest that patient-related factors might have played a role.X-ray information is crucial to understand any underlying potential failure factors and because these are not available for this case, it is not possible to establish the cause of failure for this case due to lack of adequate information.All devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the reported lot.Conclusions: the material analysis report concluded that movement between the femoral head taper and the femoral stem trunnion caused wear and material loss within the taper junction.No material or manufacturing defects were observed on the device features examined.It was not possible to determine the exact cause based on the information provided.A review by a clinical consultant concluded that no x-rays are available for review and as such it is not possible to evaluate the role of any potential procedure-related factors in the failure mode.No further investigation is possible at this time.If further information becomes available, this investigation will be re-opened.

Event Description

It was reported that there was a revision of the left accolade total hip arthroplasty.The stem was broken at the neck junction with the head.No trauma was noted by the surgeon.

Event Description

It was reported that there was a revision of the left accolade total hip arthroplasty.The stem was broken at the neck junction with the head.No trauma was noted by the surgeon.

Manufacturer Narrative

Additional information:recall (if recall number is given) or correction/removal number corrected data: common device name.An event regarding disassociation involving a metal head was reported.The event was confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: the provided medical information was submitted to a consulting clinician who confirmed the disassociation of head and stem with provided x-rays but deemed the information insufficient and rejected it for a medical review.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the provided medical information was submitted to a consulting clinician who confirmed the disassociation of head and stem with provided x-rays but deemed the information insufficient and rejected it for a medical review.Further information such as patient demographics, primary and revision operative reports, past/clinical medical history, and examination of explanted components are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.Product surveillance will continue to monitor for trends.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.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 march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.

• 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
• MDR Report Key: 5032489
• MDR Text Key: 24135282
• Report Number: 0002249697-2015-02801
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 05/30/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2012
• Device Catalogue Number: 6260-9-036
• Device Lot Number: PXYMPD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Supplement Dates Manufacturer Received: 05/04/2018
• Supplement Dates FDA Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2249697-05-07-2018-003-R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 77